目标 (Objective)

临床评价计划需首先阐明其核心目标。 即根据欧盟医疗器械法规 (EU MDR 2017/745) 的要求，全面确认待评价医疗器械在其预期用途下的安全性和临床性能，旨在满足法规第61条关于临床证据的要求，并证明器械符合通用安全和性能要求 (GSPR)，尤其是GSPR 1和GSPR 8。

此外，本节还应说明临床评价计划 (CEP) 的作用：一份详细规划如何系统收集、评估和分析待评价器械相关临床数据的文件。 收集到的数据将与该器械在正常使用条件下的预期用途所对应的当前公认临床实践和技术水平 (State of the Art, SOTA) 进行比较。 最终，本次临床评价的所有发现和结论都将完整记录在临床评价报告 (CER) 中。

输入文件 (Input Documentation)

临床评价需基于充分和可靠的现有信息。 因此，CEP中需要明确列出所有为临床评价提供信息的输入文件，至少包含：

• 文件名称/类型: 例如，最新的使用说明书 (IFU)、风险管理文件（包括风险管理计划、风险分析报告、风险管理报告）、临床前研究报告（如台架测试、动物实验报告）、生物相容性评估报告、设计验证和确认报告等。
• 文件编号: 便于追溯。
• 日期或版本: 确保使用的是最新有效版本。

待评价产品信息 (Devices Under Evaluation)

首先，提供基本的行政信息，包括制造商的法定全称、地址及其单一注册号 (SRN)。 如适用，也需列出欧盟授权代表的名称、地址和SRN。

核心是产品标识 (Device Identification)。 需要详细描述本次临床评价所涵盖的器械，通常从器械的商品名、具体型号或型号范围开始。 说明其当前的法规状态，例如是首次申请MDR CE标志，还是已有其他认证。 建议使用表格形式清晰展示产品信息，包括：

• 型号 (Model)
• 描述 (Description): 包括器械的主要构成材料、关键组件、基本技术参数等。
• CE标记日期 (CE Marking date): 若为初次申请，则注明“不适用”或“待定”。
• 分类 (Classification): 依据MDR附件八的规则，明确器械的风险等级及应用的分类规则。
• 分销区域 (Distribution Regions)
• 提供清晰的产品图片或图示有助于理解。

阐述产品的特征/功能 (Features)。 应图文并茂地说明产品独特的功能和设计特点。

然后，详细描述产品的工作原理或作用机理 (Principles of Operation)。 解释器械如何实现其预期功能及其科学依据。 若涉及复杂机制，可配合原理图说明。

清晰定义产品后，必须精确阐述其预期用途 (Intended Purpose)。 这对界定临床评价范围至关重要，且必须与产品标签、使用说明书（IFU）及风险管理文件中的描述一致。 预期用途通常包含：

• 预期用途 (Intended Use): 器械预期用于何种医疗目的、作用于人体的哪个部位、如何使用等。
• 适用症 (Indications For Use): 器械适用于哪些具体的疾病、症状或医疗状况。
• 目标患者人群 (Target Population): 适用患者的特征，如年龄范围、性别、健康状况等。
• 预期用户 (Intended Users): 操作或使用该器械的人员资质和专业背景。
• 禁忌症 (Contraindications): 哪些情况下绝对不能使用该器械。
• 警告 (Warnings): 与使用相关的潜在严重风险或安全隐患。
• 注意事项 (Precautions): 为确保安全有效使用需用户注意的事项。

与预期用途紧密相关的是临床受益 (Clinical Benefit)。 需要清晰、具体地阐述器械能为患者带来的实际临床益处，这些益处应是可量化的，并直接源于器械的安全性和性能表现。

接下来是安全和性能终点 (Performance and Safety Endpoints)。 需为器械的每一个临床宣称或预期受益，设定具体的、可测量的安全性和性能评估终点。 建议使用表格清晰呈现：

• 宣称或受益 (Claim or Benefit)
• 相关的安全和性能目标 (Safety and Performance Objectives): 针对每个宣称，列出需通过临床数据验证的具体安全和性能参数。
• 可接受标准及理由 (Acceptance Criteria with Justification): 为每个目标设定明确、可量化的成功标准，并说明设定此标准的科学依据，可来源于已发布的标准、与SOTA的对比、临床前测试结果或公认的临床实践。

然后，简要介绍设备历史 (Device History)。 说明该器械是全新研发还是基于现有器械的改进。 若是改进型，应概述其主要设计变更和更新历史。 若有在其他法规体系下的认证或市场应用历史，也应在此提及。

最后，如果待评价设备已在市场上销售，则应提供已上市设备的数量 (Number of Devices on the Market)及相关的上市后监测信息。 包括首次上市日期、已销售的大约数量，以及从真实世界使用中收集到的不良事件报告、用户投诉和任何相关的纠正/预防措施等。

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Objective

The primary objective of the clinical evaluation must be clearly articulated at the outset of the CEP. The evaluation aims to systematically confirm the safety and clinical performance of the medical device under evaluation when used for its intended purpose, in line with the EU Medical Device Regulation (EU MDR 2017/745). It should be highlighted that this process is conducted to satisfy the clinical evidence requirements stipulated in Article 61 of the MDR and to demonstrate the device’s conformity with the General Safety and Performance Requirements (GSPRs), particularly GSPR 1 (regarding achieving intended purpose safely and effectively) and GSPR 8 (concerning clinical evaluation).

This section also defines the role of the CEP itself: a detailed plan specifying how clinical data pertinent to the device will be methodically collected, rigorously assessed, and scientifically analyzed. A critical aspect involves comparing this data against the current, generally acknowledged state of the art (SOTA) relevant to the device’s intended purpose under normal conditions of use. All findings and conclusions from the clinical evaluation will be documented in the final Clinical Evaluation Report (CER).

Input Documentation

A clinical evaluation relies on an adequate and reliable foundation of existing information. Therefore, the CEP must clearly list all input documents that provide critical information for the evaluation. These documents are the starting point for planning and analysis. A comprehensive list should include at least:

• Document Title/Type: e.g., latest Instructions for Use (IFU)/User Manual, complete Risk Management File (including Risk Management Plan, Risk Analysis Report, Risk Management Report), preclinical study reports (such as bench testing, animal studies), biocompatibility assessment reports, design verification and validation reports.
• Document Number: For traceability and easy reference.
• Date or Revision: To ensure the current and effective version is utilized.

Device Under Evaluation

Initially, basic administrative information is necessary, including the manufacturer’s full legal name, detailed address, and Single Registration Number (SRN) if required (e.g., by EUDAMED). If applicable, the full name, address, and SRN of the EU Authorized Representative needs be listed.

The core of this section is Device Identification. The device(s) covered by the CEP must be described in detail. This usually begins with the device’s trade name, specific model(s), or model range (if it’s a product family), and its current regulatory status (e.g., initial MDR CE marking application or existing certifications). Using a table is recommended to clearly present product information, which should include:

• Model(s)
• Description: Including main constituent materials, key components, and basic specs.
• CE Marking Date: State “N/A” or “Pending” for initial applications.
• Classification: The device’s risk class according to MDR Annex VIII rules, including the applied classification rule.
• Distribution Regions

Following this, the product’s Features should be elaborated. Provide a detailed, illustrated description of unique functions and design characteristics.

Next, describe the product’s Principles of Operation or mechanism of action in detail. Explain how the device achieves its intended function and the scientific basis. Schematic diagrams can be useful for complex mechanisms.

The Intended Purpose of the Device Under Evaluation must be precisely stated and be consistent with the product label, IFU, and risk management documentation. This typically includes:

• Intended Use Statement: A precise definition of the medical purpose, the part of the body it acts on/in, and how it is used.
• Indications For Use: Specific diseases, symptoms, or medical conditions for which the device is indicated.
• Target Population: Characteristics of intended patients (age, sex, health status, etc.).
• Intended Users: Qualifications and professional background of personnel operating or using the device.
• Contraindications: Situations where the device must not be used.
• Warnings: Information on potential serious risks or safety hazards.
• Precautions: Measures to ensure safe and effective use and avoid non-serious problems.

Closely related is the Clinical Benefit. Articulate the actual, measurable clinical benefits the device is expected to provide to patients, directly stemming from its safety and performance.

Performance and Safety Endpoints are critical. For each clinical claim or intended benefit, establish specific, measurable, and relevant safety and performance evaluation endpoints. A table is highly recommended to present:

• Claim or Benefit: Derived from the intended purpose and clinical benefits.
• Relevant Safety (S) and Performance (P) Objectives: Specific parameters to be verified by clinical data.
• Acceptance Criteria with Justification: Clear, quantifiable success criteria and the scientific basis for them (e.g., published standards, SOTA comparisons, preclinical test results, accepted clinical practice).

Briefly introduce the Device History. State if the device is new or an improvement on an existing one. If modified, outline main design changes and update history. Mention any previous certifications or market history in other regions.

Finally, if the device is already marketed (even outside the EU or under previous directives), provide the Number of Devices on the Market and relevant post-market surveillance (PMS) information. This includes the first marketing date, approximate units sold, and a summary of adverse event reports, user complaints, and any related corrective/preventive actions from real-world use.

临床评价计划（CEP）中的“临床背景信息 (State-of-the-Art, SOTA)”章节，是确立待评价医疗器械临床价值和定位的关键环节。本章的核心目标是系统、客观地阐述与器械相关的当前医学知识体系和临床实践标准。通过对相关疾病、现有诊疗手段、可替代方案及其公认安全性和有效性水平的清晰界定，SOTA为后续临床评价的范围、终点选择和可接受标准的设定提供了必要的基准。

临床背景 (Clinical Background)

此部分为待评价器械所应用的特定医学领域构建一个清晰、全面的认知框架。

首先，需要精确界定与器械预期用途直接相关的特定医学状况或疾病。这包括对该疾病的定义、流行病学特征（如患病率、发病率，以及相关的人口统计学特征如年龄、性别分布）、主要的风险因素和公认的病理生理机制进行系统性描述。随后，应详细阐述该疾病的临床表现谱系，从早期或无症状阶段，到疾病进展后的各种典型症状和体征，直至最严重的临床阶段。此外，对疾病的自然病程、发展趋势和总体预后也应有所说明。所有这些描述均需基于当前公认的医学文献和权威数据，并规范引用来源。

在对疾病概况进行清晰阐述后，应过渡到对当前临床实践中存在的挑战和未满足的临床需求进行分析。这要求识别并阐明在现有诊疗模式下，针对该疾病的诊断、治疗或长期管理等方面仍然存在的不足或难题。例如，这可能涉及特定患者亚群的诊断准确性问题，不同治疗技术快速发展背景下临床实践标准的不统一，或在某些精细操作层面缺乏标准化指南。此外，现有治疗方法在提升远期疗效方面的局限，医疗资源配置不均导致的诊疗可及性差异，或特定病理改变给临床操作带来的技术壁垒等，均是值得探讨的方面。准确识别这些未满足的需求，有助于后续论证待评价器械的潜在临床贡献。

然后，需要系统概述针对该疾病的现有诊断方法和标准化流程。应从基础的临床评估（包括详细的病史采集和体格检查）入手，逐步介绍并评估各项核心的无创及有创诊断技术。在此过程中，应结合并引用相关专业学会发布的临床指南（如NICE, ACC/AHA, ESVS等）中关于诊断路径的推荐，以体现当前规范化的诊断实践。

在诊断方法之后，应详尽阐述针对该疾病的主流治疗策略及公认的“金标准”疗法（如有）。这通常始于对基础性、综合性治疗措施的介绍，如生活方式干预（例如戒烟指导）、危险因素的系统管理（例如控制高血压、糖尿病、高脂血症）以及核心的药物治疗方案（例如抗血小板药物、他汀类药物的应用）。针对疾病的不同分期、分型或严重程度，应分别阐述其推荐的治疗方案和层级。在讨论各种治疗方案时，还应分析其选择的循证医学依据，如患者风险分层、病变解剖特点等。引用权威临床指南的推荐意见是确保这部分内容专业性的关键。

最后，对于与待评价器械类型相关（或由其辅助的关键医疗程序）的临床应用，须明确阐述行业内公认的、用于评估其安全性和性能的临床终点。同时，也需全面审视相关的安全性终点，如围手术期并发症和远期不良事件。若器械本身具有特定的性能参数对其临床应用非常关键，则应一并讨论这些参数，以及可能由器械直接导致的特有不良事件，并结合标准操作规范和使用建议进行说明。在阐述这些终点时，应尽可能提供来自已发表文献或指南的、具有代表性的量化数据或可接受范围。适时采用表格形式总结关键国际指南的核心推荐或重要数据。

可替代治疗方案 (Alternative Options)

本节旨在客观、全面地介绍除待评价器械（或其相关疗法）之外，当前临床上可用的其他可替代治疗方案。

首先，应对这些替代方案进行系统的梳理和描述。根据其性质，这些方案可大致归类为：

• 保守治疗或非干预性管理
• 其他类型的介入或外科治疗技术
• 其他可能相关的辅助或特殊治疗手段

在对各种替代方案进行充分描述之后，核心环节是进行审慎的对比分析。这意味着需要将待评价器械（或其所支持的核心治疗程序）与这些替代方案，在公认的关键安全性和性能临床终点上进行客观的比较。此类比较必须基于高质量的循证医学证据，如已发表的随机对照试验（RCTs）、系统评价（Systematic Reviews）和荟萃分析（Meta-analyses），以及权威临床指南的推荐。清晰、规范地引用这些证据来源至关重要。在叙述复杂的对比数据时，辅以设计良好的表格进行总结，可以显著增强信息的可读性和影响力。进行对比分析时，必须保持中立和客观，既要合理呈现待评价器械（或其相关疗法）相较于部分替代方案可能存在的临床获益或特点，也要如实反映其可能存在的不足，或与其他成熟方案在效能与安全性上的可比性。

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The “Clinical Background (State-of-the-Art, SOTA)” chapter within the Clinical Evaluation Plan (CEP) is a critical segment for establishing the clinical value and positioning of the medical device under evaluation. The core objective of this chapter is to systematically and objectively articulate the current body of medical knowledge and standard clinical practices relevant to the device. By clearly defining the associated disease(s), existing diagnostic and therapeutic modalities, alternative treatment options, and their generally accepted levels of safety and performance, the SOTA provides essential context and benchmarks for the subsequent determination of the clinical evaluation’s scope, endpoint selection, and acceptance criteria.

Clinical Background

This section is dedicated to constructing a clear and comprehensive cognitive framework for the specific medical field in which the device under evaluation will be applied.

Firstly, the specific medical condition or disease directly related to the device’s intended use must be precisely defined. This involves a systematic description of the disease’s definition, epidemiological characteristics (such as prevalence, incidence, and relevant demographic features like age and gender distribution), primary risk factors, and recognized pathophysiological mechanisms. Subsequently, the spectrum of clinical manifestations of the disease should be detailed, progressing from early or asymptomatic stages, through various typical signs and symptoms as the disease advances, to the most severe clinical phases. Furthermore, information on the natural history, progression, and overall prognosis of the disease should be included. All such descriptions must be grounded in currently accepted medical literature and authoritative data, with appropriately cited sources.

Following a clear exposition of the disease overview, the narrative should transition to an analysis of the existing challenges and unmet clinical needs within current clinical practice. This requires identifying and articulating the deficiencies or difficulties that persist in the diagnosis, treatment, or long-term management of the disease under the prevailing healthcare models. For instance, this might involve issues with diagnostic accuracy in specific patient subgroups, inconsistencies in clinical practice standards amidst the rapid evolution of different treatment technologies, or a lack of standardized guidelines for certain refined procedures. Additionally, limitations in enhancing long-term efficacy with current treatment methods, disparities in access to diagnosis and treatment due to uneven resource allocation, or technical barriers posed by specific pathological changes are all aspects worthy of discussion. Accurately identifying these unmet needs helps to subsequently substantiate the potential clinical contribution of the device under evaluation.

Next, a systematic overview of current diagnostic methods and standardized procedures for the disease is required. This should begin with fundamental clinical assessments (including detailed history taking and physical examination) and progressively introduce and evaluate core non-invasive and invasive diagnostic techniques. Throughout this process, recommendations from relevant professional society clinical guidelines (e.g., NICE, ACC/AHA, ESVS) concerning diagnostic pathways should be integrated and cited to reflect current standardized diagnostic practice.

Subsequent to diagnostic methods, mainstream therapeutic strategies and recognized “gold standard” therapies (if any exist) for the disease should be exhaustively detailed. This typically begins with an introduction to foundational, comprehensive treatment measures, such as lifestyle interventions (e.g., smoking cessation advice), systematic management of risk factors (e.g., control of hypertension, diabetes, hyperlipidemia), and core pharmacological treatment regimens (e.g., application of antiplatelet agents, statins). For different stages, types, or severities of the disease, their respective recommended treatment plans and hierarchical approaches should be elucidated. When discussing various treatment options, the evidence-based rationale for their selection, such as patient risk stratification and anatomical lesion characteristics, should also be analyzed. Citing recommendations from authoritative clinical guidelines is key to ensuring the professionalism of this section.

Finally, concerning the clinical application related to the type of device under evaluation (or the key medical procedure it facilitates), it is imperative to clearly articulate the industry-accepted clinical endpoints used to assess its safety and performance. If the device itself has specific performance parameters crucial to its clinical application, these parameters should be discussed along with any unique adverse events directly attributable to the device, explained in conjunction with standard operating procedures and usage recommendations. When presenting these endpoints, quantitative data or acceptable ranges from published literature or guidelines should be provided whenever possible. The appropriate use of tables to summarize core recommendations from key international guidelines or significant data can enhance the efficiency and clarity of information delivery.

Alternative Options

This section aims to objectively and comprehensively present other currently available alternative treatment options in clinical practice, aside from the device under evaluation (or its related therapy).

Firstly, these alternative options should be systematically reviewed and described. Depending on their nature, these options can be broadly categorized as:

• Conservative treatment or non-interventional management
• Other types of interventional or surgical treatment technique
• Other potentially relevant adjunctive or special treatment modalities

Following a thorough description of the various alternative options, the core element is to conduct a judicious comparative analysis. This entails objectively comparing the device under evaluation (or the core therapeutic procedure it supports) with these alternatives against recognized key clinical endpoints for safety and performance. Such comparisons must be based on high-quality, evidence-based medicine, such as published randomized controlled trials (RCTs), systematic reviews, and meta-analyses, as well as recommendations from authoritative clinical guidelines. Clear and standardized citation of these evidence sources is crucial. When narrating complex comparative data, supplementing with well-designed tables for summary can significantly enhance the readability and impact of the information. When conducting comparative analysis, neutrality and objectivity must be maintained, reasonably presenting potential clinical benefits or characteristics of the device under evaluation (or its related therapy) compared to some alternatives, while also truthfully reflecting its possible shortcomings or its comparability in efficacy and safety with other established options.

在临床评价计划（CEP）中，“基准或类似产品”这一章节旨在通过识别和描述市场上已存在的、与待评价器械具有可比性的产品，为临床评价提供重要的参照。本章的目的是提供在当前技术背景下，与待评价器械在设计、预期用途或技术特性等方面相近或可作为标杆的产品概况。这有助于评估者理解待评价器械的技术定位，并为后续的等同性论证（如适用）、性能与安全性可接受标准的设定，以及风险效益分析提供依据。

撰写本章节时，核心在于如何选择合适的对比产品，并以专业、精炼的方式呈现其关键信息，同时阐明其与待评价器械的关联性。

选择基准或类似产品的考量

选择哪些产品作为基准或类似产品，应基于明确且合理的标准。通常，应优先考虑那些在以下一个或多个方面与待评价器械具有显著相关性的产品：

• 预期用途和适应症： 选择那些预期用途、目标患者人群和临床应用场景与待评价器械高度一致或非常相似的产品。
• 技术特性和作用机理： 关注那些采用相似技术原理、关键设计或作用机制的产品。
• 材料和构造： 对于材料依赖性较强的器械，其主要材料的相似性也是一个重要的考量点。
• 市场代表性和公认度： 选择那些在目标市场（尤其是欧盟市场）上已有良好应用历史、被临床广泛接受、或能代表当前技术发展水平（State-of-the-Art）中成熟技术的产品。
• 法规状态： 通常选择已获得CE认证（依据MDR或MDD）或在其他主要监管区域（如FDA批准/许可）上市的产品。
• 等同性论证需求： 如果计划通过与某一已上市器械的等同性路径进行临床评价，则该“等同器械”将是在对应章节进行详细对比分析。

描述选定的基准或类似产品

对于每一个选定的基准或类似产品，应提供一段简洁而信息丰富的介绍。盲目罗列大量参数并不可取，关键在于提取并呈现那些对于理解该产品特性及其与待评价器械之可比性最为关键的信息。通常，对每个产品的描述包含以下方面：

首先，清晰标明该产品的准确名称、型号（如果适用）及其制造商。紧接着，简要说明其在主要市场的法规状态，例如是否已获得CE标志及其依据的法规（MDR/MDD），或在美国的FDA批准/许可情况。

核心内容在于阐述该产品的预期用途和适应症，这直接关系到其与待评价器械的临床可比性。随后，应聚焦于其关键的设计和技术特征。这部分内容需要根据器械的类型具体展开，例如： * 对于有源器械，可能涉及其工作原理、关键性能参数（如能量输出范围、频率等）。 * 对于无源植入物，则可能侧重于其主要结构材料、表面处理、机械性能指标等。 * 对于体外诊断试剂，则关注其检测原理、样本类型、主要分析性能（如灵敏度、特异性）等。

如果能够从公开渠道（如产品IFU、制造商官网、已发表文献、监管机构数据库等）获取到关于该产品已知的安全性和性能概况的总结性信息，且这些信息对于后续的比较分析具有实质意义，也应在此简要提及。例如，已知的临床应用效果、主要并发症发生率等。

阐明与待评价器械的关联性

在描述完每个基准或类似产品的基本情况后，阐明该产品为何被选中，以及它与正在进行临床评价的器械之间的具体关联。例如，它是作为等同性论证的前提（即“等同器械”）？还是代表了当前市场上同类产品的主流技术水平？或是因其某一特定设计或性能特点与待评价器械具有高度可比性？阐明这种关联性，能够帮助读者理解选择这些特定产品进行比较的逻辑和意义。

信息的组织与呈现

虽然在CEP的这一章节中，对每个基准或类似产品的核心特性进行系统化对比有时是必要的。例如，当比较多个产品在多个维度上的参数时，在CEP内部适当使用表格归纳这些具体参数（如材料、性能指标等）可以使信息一目了然。在逐一介绍完产品后，可以有一小段总结，提炼出从这些基准或类似产品中观察到的共性、差异性，及其对评价待评价器械的启示。

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In the Clinical Evaluation Plan (CEP), the “Benchmark or Similar Devices” chapter serves to provide a crucial frame of reference for the clinical evaluation by identifying and describing existing devices on the market that are comparable to the device under evaluation. The purpose of this chapter is to clearly delineate the landscape of products that are similar or can serve as benchmarks in terms of design, intended use, or technological characteristics within the current state of the art. This facilitates the evaluator’s understanding of the technological positioning of the device under evaluation and provides a basis for subsequent equivalence demonstrations (if applicable), the establishment of performance and safety acceptance criteria, and the benefit-risk analysis.

When composing this chapter, the core lies in selecting appropriate comparator devices and presenting their key information in a professional and concise manner, while also articulating their relevance to the device under evaluation.

Considerations for Selecting Benchmark or Similar Devices

The selection of devices as benchmarks or comparators should not be arbitrary but based on clear and justifiable criteria. Typically, priority should be given to products that demonstrate significant relevance to the device under evaluation in one or more of the following aspects:

• Intended Use and Indications: Select products whose intended use, target patient population, and clinical application scenarios are highly consistent or very similar to those of the device under evaluation.
• Technological Characteristics and Mechanism of Action: Focus on products that employ similar technological principles, key designs, or mechanisms of action.
• Materials and Construction: For devices where materials are a critical aspect, the similarity of principal materials is also an important consideration.
• Market Representation and Acceptance: Choose products that have a well-established history of use in the target market (especially the EU market), are widely accepted clinically, or represent mature technologies within the current state-of-the-art (SOTA).
• Regulatory Status: Generally, select products that have already obtained CE marking (under MDR or MDD) or are marketed in other major regulatory jurisdictions (e.g., FDA cleared/approved).
• Equivalence Demonstration Needs: If the clinical evaluation pathway involves demonstrating equivalence to a device already on the market, then that “equivalent device” will be compared with the device under evaluation in the relevant chapter.

Describing Selected Benchmark or Similar Devices

For each selected benchmark or similar device, a concise informative profile should be presented. A mere laundry list of numerous parameters is not advisable; the key is to extract and present the information most critical for understanding the device’s characteristics and its comparability to the device under evaluation. Typically, the description for each device should include the following aspects:

Begin by clearly stating the accurate name of the product, model number (if applicable), and its manufacturer. Following this, briefly outline its regulatory status in key markets, such as whether it has obtained a CE mark and the regulation it conforms to (MDR/MDD), or its FDA clearance/approval status in the United States.

The core content should focus on articulating the product’s intended use and indications for use, as this directly relates to its clinical comparability with the device under evaluation. Subsequently, the description should center on its key design and technological features. This part needs to be elaborated based on the type of device, for example: * For active devices, this might involve their operating principles, key performance parameters (e.g., energy output range, frequency). * For passive implants, the focus might be on their main structural materials, surface treatments, mechanical performance indicators. * For in-vitro diagnostic devices, attention would be on their detection principles, sample types, and main analytical performance characteristics (e.g., sensitivity, specificity).

If summary information regarding the known safety and performance profile of the product can be obtained from public sources (such as product IFUs, manufacturer websites, published literature, regulatory agency databases), and this information is substantively relevant for subsequent comparative analysis, it should also be briefly mentioned here. For instance, known clinical application outcomes, or rates of major complications.

Articulating Relevance to the Device Under Evaluation

After describing the basic situation of each benchmark or similar device, clearly articulate why that product was selected and its specific relationship to the device undergoing clinical evaluation. For example, is it a predicate for an equivalence claim (i.e., an “equivalent device”)? Does it represent the mainstream technological level of similar products currently on the market? Or is it highly comparable to the device under evaluation due to a specific design or performance characteristic? Clarifying this relationship helps the reader understand the logic and significance behind choosing these particular devices for comparison.

Organizing and Presenting Information

While a systematic comparison of the core characteristics of each benchmark or similar device is sometimes necessary within this CEP chapter, for instance, when comparing multiple products across several parameters, appropriately using internal tables to summarize these specific parameters (such as materials, performance indicators) can make the information readily understandable. After introducing each product individually, a brief summary can distill commonalities, differences observed among these benchmark or similar devices, and their implications for evaluating the device under evaluation.

在临床评价计划（CEP）中，若计划通过与一个或多个已合法上市的医疗器械（即“等同器械”）进行比对，并利用其临床数据来支持待评价器械的安全性和性能，则必须设立一个专门的章节来严谨、详尽地论证这种“等同性”。本章节的核心任务是依据法规要求（如欧盟MDR法规第61条第3款及附件XIV A部分第3节，并参考MDCG 2020-5等指南文件），清晰、系统地证明待评价器械与所选定等同器械在临床、技术和生物学特性方面不存在任何具有临床显著性的差异。

等同器械的选择标准

在开始详细的比较之前，首先必须阐明选择特定器械作为等同器械的理由和标准。选择的等同器械应为已在欧盟市场合法销售（通常带有CE标志）的产品。其选择不应仅基于表面相似，而必须能够承受在以下三个关键维度上进行的细致比较：

1. 临床等同性： 器械需用于相同的临床状况（包括相似的疾病状态和严重程度）、相同的预期目的（包括相似的治疗或诊断效果）、相似的目标人群（包括年龄、解剖结构、健康状况等方面的考量）、以及相似的使用部位和应用方法。
2. 技术等同性： 器械需采用相似的设计和技术规格（例如，相似的工作原理、关键性能参数、部署方法、以及与待评价器械类似的关键部件的材料和设计）、在相似的使用条件下使用，并具有相似的软件算法（如适用）。
3. 生物学等同性： 器械需采用与人体组织接触的相同材料或高度相似的材料，且这些材料与人体的接触性质和时长也应相似。

系统性地论证等同性

等同性的论证是一个系统化、细致的对比过程，非简单罗列。需要在CEP中概述这一过程，并计划在临床评价报告（CER）中完整呈现详细的对比数据和分析。

核心环节是进行逐项的特性比较。需要将待评价器械与每一个选定的等同器械，就所有相关的临床、技术和生物学特性进行并列比较。常通过表格形式清晰展示各项特征在不同器械间的具体表现，对比应覆盖的范围广泛，例如：

• 临床特性方面： 详细对比预期用途的每一个细节、适应症的范围、目标患者群体的精确定义、目标疾病或状况的特性、器械在体内的具体使用部位，乃至禁忌症、警告和注意事项的表述差异等。
• 技术特性方面： 深入剖析设计特点（如：特定的几何形状、能量输出参数、软件版本等）、作用机制或工作原理的异同、关键性能规格（如尺寸范围、机械强度、输送系统的兼容性等）、灭菌方法及无菌屏障系统、以及是否为一次性使用等。
• 生物学特性方面： 明确列出所有与人体直接或间接接触的材料成分，评估这些材料的生物相容性数据，并比较与人体组织的接触方式和预期接触时长。

差异的识别与分析

在进行细致的逐项比较时，几乎不可避免地会发现待评价器械与等同器械之间存在某些差异。必须明确识别出所差异。

一旦识别出差异，需要对每一项差异进行深入的科学分析和论证，以证明这些差异不会对器械的安全性和/或临床性能产生具有临床显著性的负面影响。这种分析需要：

• 清晰描述差异的性质和程度。
• 基于科学原理、工程评估、标准要求、已发表文献或特定的临床前研究（如台架测试、动物实验）来解释为何该差异不会导致临床结果（如有效性、并发症发生率、操作便捷性等）的不同。
• 如果差异涉及材料，需评估其生物相容性、化学性质、物理性质等方面的潜在影响。
• 如果差异涉及设计或性能规格，需评估其对器械在预期临床场景下按预期运行的能力的影响。

在CEP中规划和呈现等同性论证

在临床评价计划（CEP）的本章节中，需要清晰地阐述进行等同性论证的计划和方法学。

应首先明确声明计划与哪些特定的、已合法上市的器械进行等同性论证，并简述选择这些器械的主要理由。

接着，概述将如何进行临床、技术和生物学特性的详细比较。可以提及计划采用的比较参数的范围。重点在于说明将如何系统地识别差异，并对这些差异的临床显著性进行评估和论证。

CEP应指明支持等同性论证所需的数据来源。这可能包括：

• 制造商内部已完成的或计划中的临床前研究（如台架测试、模拟使用测试、动物研究等，特别是那些直接头对头比较待评价器械与等同器械性能的测试）。
• 对已发表科学文献的系统检索和分析，以获取关于等同器械特性、性能、安全性以及某些技术或材料差异临床影响的信息。
• 对相关国际标准和指南的遵循情况。
• 对等同器械的上市后监测数据、不良事件报告、临床研究数据（如有）的计划性检索和分析。

本章节应为后续临床评价报告（CER）中如何利用已证实的等同性来支持待评价器械的临床安全性和性能，设定一个清晰的路径。例如，说明在CER中将如何整合和评价来自等同器械的临床数据。

等同性的论证是监管机构审查的重点之一。整个过程必须透明、严谨、科学，并充分符合相关的法规指南（如MDCG 2020-5）的要求。任何宣称的等同性都必须有充分的证据支持，且对差异的分析必须具有说服力。

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Within the Clinical Evaluation Plan (CEP), if the strategy involves comparing the device under evaluation with one or more legally marketed medical devices (i.e., “equivalent devices”) and leveraging their clinical data to support the safety and performance claims of the new device, a dedicated chapter is essential to rigorously and comprehensively substantiate this “equivalence.” The core task of this chapter is to clearly and systematically demonstrate, in accordance with regulatory requirements (such as EU MDR Article 61(3) and Annex XIV Part A Section 3, with reference to guidance documents like MDCG 2020-5), that no clinically significant differences exist between the device under evaluation and the chosen equivalent device(s) in terms of their clinical, technical, and biological characteristics.

Selection Criteria for Equivalent Devices

Before embarking on a detailed comparison, it is imperative to first articulate the rationale and criteria for selecting specific devices as equivalent. The chosen equivalent device(s) should be products legally marketed in the EU (typically bearing a CE mark). Their selection should not be based merely on superficial similarity but must withstand meticulous comparison across three key dimensions:

1. Clinical Equivalence: The devices must be used for the same clinical condition (including similar disease state and severity), for the same intended purpose (including similar therapeutic or diagnostic effects), in similar target populations (considering aspects like age, anatomy, health status), and at similar sites of use and with similar application methods.
2. Technical Equivalence: The devices must utilize similar designs and technical specifications (e.g., similar operating principles, key performance parameters, deployment methods, and materials and designs of critical components analogous to the device under evaluation), be used under similar conditions of use, and possess similar software algorithms (if applicable).
3. Biological Equivalence: The devices must use the same or highly similar materials in contact with human tissues, and the nature and duration of this contact with the body must also be similar.

Systematically Demonstrating Equivalence

The demonstration of equivalence is a systematic and highly detailed comparative process, not a simple listing. You need to outline this process in the CEP, with the plan to present the full detailed comparative data and analysis in the Clinical Evaluation Report (CER).

The core activity is a feature-by-feature comparison. This means juxtaposing the device under evaluation with each selected equivalent device across all relevant clinical, technical, and biological characteristics. This comparison should be extensive, covering areas such as:

• Clinical Characteristics: A detailed comparison of every aspect of the intended use, the scope of indications, precise definitions of target patient populations, characteristics of the target disease or condition, specific anatomical sites of use, and even differences in the wording of contraindications, warnings, and precautions.
• Technical Characteristics: An in-depth analysis of design features (e.g., specific geometric shapes, energy output parameters, software versions, etc.), similarities and differences in the mechanism of action or operating principle, key performance specifications (such as dimensional ranges, mechanical strength, delivery system compatibility), sterilization methods and sterile barrier systems, and whether they are designated for single use.
• Biological Characteristics: A clear listing of all material components that come into direct or indirect contact with the human body, an assessment of the biocompatibility data for these materials, and a comparison of the mode and intended duration of contact with human tissues.

Identification and Analysis of Differences

When conducting a meticulous feature-by-feature comparison, it is almost inevitable that some differences will be found between the device under evaluation and the equivalent device(s). All such differences must be transparently identified.

Once differences are identified, an in-depth scientific analysis and justification for each difference to prove that it does not have a clinically significant negative impact on the safety and/or clinical performance of the device must be conducted. Such an analysis requires:

• A clear description of the nature and extent of the difference.
• An explanation, based on scientific principles, engineering assessments, standard requirements, published literature, or specific preclinical studies (such as bench testing, animal studies) of why this difference will not lead to different clinical outcomes (e.g., in efficacy, complication rates, ease of use).
• If the difference involves materials, an assessment of potential impacts on biocompatibility, chemical properties, physical properties, etc.
• If the difference involves design or performance specifications, an assessment of its impact on the device’s ability to perform as intended in the anticipated clinical scenario.

Planning and Presenting the Equivalence Argument in the CEP

In this chapter of the Clinical Evaluation Plan (CEP), you need to clearly articulate the plan and methodology for demonstrating equivalence.

It should begin by explicitly stating which specific, legally marketed device(s) are intended for the equivalence demonstration and briefly outline the primary reasons for their selection.

Next, provide an overview of how the detailed comparison of clinical, technical, and biological characteristics will be conducted. You can mention the planned scope of comparative parameters. The emphasis should be on describing how differences will be systematically identified, and how their clinical significance will be assessed and justified.

The CEP should indicate the data sources required to support the equivalence demonstration. This may include:

• Manufacturer’s internal completed or planned preclinical studies (e.g., bench tests, simulated use tests, animal studies, especially those directly comparing the performance of the device under evaluation against the equivalent device(s)).
• Systematic retrieval and analysis of published scientific literature to obtain information on the characteristics, performance, and safety of the equivalent device(s), as well as the clinical impact of certain technical or material differences.
• Adherence to relevant international standards and guidelines.
• Planned retrieval and analysis of post-market surveillance data, adverse event reports, and clinical study data for the equivalent device(s) (if available).

This chapter should set a clear path for how the demonstrated equivalence will be used in the subsequent Clinical Evaluation Report (CER) to support the clinical safety and performance of the device under evaluation. For example, it should state how clinical data from the equivalent device(s) will be integrated and appraised in the CER.

Tthe demonstration of equivalence is a key area of scrutiny by regulatory authorities. The entire process must be transparent, rigorous, scientific, and fully compliant with relevant regulatory guidance (such as MDCG 2020-5). Any claim of equivalence must be substantiated by robust evidence, and the analysis of differences must be convincing.

在临床评价计划（CEP）中，“风险管理”章节的核心目的并非重新执行风险管理活动，而是清晰阐述风险管理过程如何与临床评价活动相互关联、相互输入，并共同确保待评价医疗器械的受益风险比在预期用途下是可接受的。本章节应概述已识别的临床相关风险，以及计划如何通过临床评价来进一步确认这些风险的可控性和可接受性。

撰写本章节时，应体现风险管理与临床评价之间持续的、双向的互动关系，这是符合MDR法规要求的关键。

关联现有的风险管理框架

首先，本章节应明确指出制造商已经按照适用的标准（如ISO 14971）和MDR的要求，建立并运行了一套完整的风险管理过程。临床评价计划是在这个既定的风险管理框架基础上进行的。因此，需要概述风险管理过程是如何识别与待评价器械相关的临床风险的。通常，这些信息来源于一系列核心的风险管理文件，例如风险管理计划、危害分析（HA，可能包括使用危害分析、设计危害分析等）、过程/制造FMEA（PFMEA），以及最终的风险管理报告。在CEP中提及这些文件，能够表明临床评价所依据的风险背景是有据可查的。

临床评价中需关注的已识别风险

在阐述了风险管理的总体框架后，CEP应简要说明通过上述风险管理活动，已经识别出哪些与待评价器械临床使用相关的重大风险。这包括对这些风险（包括初始风险以及经过风险控制措施缓解后的剩余风险）的初步评估情况，以及其可接受性是如何依据风险管理计划中预设的标准（通常在风险管理报告中有详细论述）进行判定的。

此外，还应说明已采取的风险控制措施，例如符合协调标准、规定器械的有效使用期限、维护保养要求以及通过标签和说明书提供安全使用信息等，是如何致力于将这些风险降低到尽可能低的水平（AFARP）的。

临床评价在确认剩余风险可接受性中的作用

CEP需要清晰地阐明临床评价的一项核心作用（也是CEP所规划的主要活动之一）是收集和分析临床数据，用以进一步确认在器械带来预期受益并参照当前技术发展水平（SOTA）的前提下，那些已识别的剩余风险的可接受性。临床评价将特别关注与这些剩余风险相关的实际发生率、临床表现的严重程度，以及它们在真实世界临床应用中的具体影响。

评估临床风险的数据来源规划

为实现上述目标，CEP应概述在临床评价过程中计划收集和分析哪些类型的数据来评估和确认临床风险。这部分内容需要与临床评价的整体数据收集策略相呼应。可能的数据来源包括：

• 来自临床前研究的数据，特别是那些验证和确认器械设计符合相关安全标准（例如，协调标准等）的测试结果。
• 关于待评价器械或具有可比性的类似/等同器械的已发表文献中的临床数据。
• 来自待评价器械或类似/等同器械的上市后监测（PMS）数据，包括用户投诉、警戒系统报告、趋势报告等。
• 如果计划或正在进行临床研究，那么从中获得的临床数据也是评估风险的核心证据之一。

确保一致性与风险管理的动态更新

在整个产品生命周期中，风险管理文件、临床评价结果以及提供给用户的信息（如标签、使用说明书）之间保持持续一致性是非常重要的。CEP中应明确，在后续的临床评价报告（CER）中，将对这种一致性进行审查和确认。

风险管理本身是一个动态的、持续改进的过程。因此，CEP必须阐明这种互动机制：如果在临床评价过程中（包括文献回顾、PMS数据分析或临床研究），发现了任何先前未预见到的新危害，或者现有风险的严重性、发生率或可探测性被重新估计，或是对器械的受益风险平衡产生了新的疑问，这些信息都将及时反馈至风险管理流程。这将可能触发对风险评估文件的更新，必要时还将促使制造商制定并实施额外的风险控制措施。

与当前技术发展水平（SOTA）的关联

风险的可接受性判断往往需要参照当前公认的技术发展水平。因此，CEP中也应说明在评估风险时，会结合SOTA中关于同类器械可接受的风险水平和受益情况进行综合考量。

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In the Clinical Evaluation Plan (CEP), the primary purpose of the “Risk Management” chapter is not to re-execute risk management activities, but rather to clearly articulate how the risk management process and clinical evaluation activities interrelate and provide input to each other, collectively ensuring that the benefit-risk profile of the device under evaluation is acceptable for its intended use. This chapter should outline the identified clinical risks and detail how the clinical evaluation is planned to further confirm the controllability and acceptability of these risks.

When drafting this chapter, it is crucial to reflect the continuous, bi-directional interaction between risk management and clinical evaluation, a key requirement under the MDR.

Referencing the Existing Risk Management Framework

This chapter should explicitly state that the manufacturer has established and maintains a comprehensive risk management process in accordance with applicable standards (e.g., ISO 14971) and MDR requirements. The Clinical Evaluation Plan is developed within this established risk management framework. Therefore, it is necessary to outline how the risk management process has identified clinical risks associated with the device under evaluation. Typically, this information is derived from a series of core risk management documents, such as the Risk Management Plan, Hazard Analysis (HA, which may include Application HA, Design HA, etc.), Process/Manufacturing FMEA (PFMEA), and ultimately, the Risk Management Report. Referencing these documents in the CEP demonstrates that the risk context for the clinical evaluation is well-documented.

Identified Risks to be Addressed in Clinical Evaluation

After outlining the overall risk management framework, the CEP should briefly describe the significant clinical risks associated with the clinical use of the device under evaluation that have been identified through the aforementioned risk management activities. This includes the preliminary assessment of these risks (both initial risks and residual risks after mitigation by risk control measures) and how their acceptability has been determined against predefined criteria set forth in the Risk Management Plan (usually detailed in the Risk Management Report).

Furthermore, it should be explained how implemented risk control measures—such as conformity to harmonized standards, specification of the device’s useful lifetime, maintenance requirements, and provision of safety information through labeling and instructions for use—are intended to reduce these risks to a level as low as reasonably practicable (AFARP).

Role of Clinical Evaluation in Confirming Acceptability of Residual Risks

The CEP needs to clearly articulate that a core function of the clinical evaluation (and a primary activity planned within this CEP) is to collect and analyze clinical data. This data is used to further confirm the acceptability of the identified residual risks, considering the device’s claimed benefits and by reference to the current state-of-the-art (SOTA). The clinical evaluation will specifically focus on the actual occurrence rates, the severity of clinical manifestations, and the real-world clinical impact of these residual risks.

Planned Data Sources for Evaluating Clinical Risks

To achieve the above objective, the CEP should outline the types of data planned for collection and analysis during the clinical evaluation to assess and confirm clinical risks. This section needs to align with the overall data collection strategy of the clinical evaluation. Potential data sources include:

• Data from preclinical studies, particularly test results that verify and validate the device design’s conformity to relevant safety standards (e.g., harmonized standards).
• Clinical data from published literature on the device under evaluation (if any) or on comparable similar/equivalent devices.
• Post-Market Surveillance (PMS) data from the device under evaluation or similar/equivalent devices, including user complaints, vigilance system reports, trend reports, etc.
• If clinical investigations are planned or ongoing, the clinical data obtained from these will naturally be core evidence for risk assessment.

Ensuring Consistency and Dynamic Updates to Risk Management

It is important to emphasize the continuous maintenance of consistency throughout the product lifecycle between the risk management documentation, the information provided to users (e.g., labeling, Instructions for Use – IFU), and the findings of the clinical evaluation. The CEP should anticipate that this consistency will be reviewed and confirmed in the subsequent Clinical Evaluation Report (CER).

More critically, risk management itself is a dynamic, iterative process. Therefore, the CEP must articulate this interactive mechanism: if the clinical evaluation process (including literature reviews, PMS data analysis, or clinical investigations) uncovers any previously unforeseen new hazards, or if the severity, occurrence, or detectability of existing risks is re-estimated, or if new questions arise concerning the device’s benefit-risk balance, this information will be promptly fed back into the risk management process. This may trigger updates to risk assessment documents and, if necessary, prompt the manufacturer to develop and implement additional risk control measures.

Linkage to State-of-the-Art (SOTA)

The judgment of risk acceptability often needs to be made by reference to the currently accepted state-of-the-art. Therefore, the CEP should also mention that the assessment of risks will involve a comprehensive consideration of acceptable risk levels and benefits associated with similar devices, as documented in the SOTA.

在临床评价计划（CEP）中，“临床开发计划 (CDP)”章节扮演着规划蓝图的角色，它清晰勾勒出制造商为证明待评价医疗器械符合相关通用安全和性能要求（GSPR），并确认其在整个生命周期内的受益风险比所规划的一系列临床证据收集与评估活动。本章节应呈现一个从现有数据评估到必要的临床研究（如有必要），再到上市后临床跟踪（PMCF）的逻辑清晰、分阶段实施的策略。其详略程度应与器械的风险等级、创新程度、现有数据的充分性以及相关法规要求（如MDR附件XIV A部分1(a)）相匹配。

本部分内容应体现制造商对临床证据收集的前瞻性规划和承诺。

明确临床开发的当前阶段与总体策略

首先，CDP应简明扼要地阐述待评价器械当前的临床开发阶段。例如，是全新设计的器械寻求初次CE认证，还是对已上市器械的重大改型，或是基于成熟技术的迭代产品。这一背景信息直接影响后续临床证据收集策略的制定。

在此基础上，应概述获取和/或产生临床证据的总体策略。这包括说明计划如何利用现有数据，以及在现有数据不足以充分证明安全性和性能时，将如何通过新的临床研究来弥补差距。

现有临床相关数据的整合与利用计划

CDP应详细说明计划如何系统地收集、整合和评估已有的临床相关数据。这些数据来源可能包括：

• 临床前研究数据： 这是证明器械符合其技术规格和基本安全性能要求的基础。应概述已完成的关键临床前研究（如台架测试、模拟使用、动物实验等）及其主要结论如何支持临床安全性和性能的初步评估。
• 现有已发表文献数据： 说明计划如何对与待评价器械本身（如果存在相关文献）、或具有相似技术特性和预期用途的同类或等同器械相关的科学文献进行系统性检索、筛选和评价。
• 来自等同器械的数据（如适用）： 若在CEP的前续章节中已成功论证了与一个或多个等同器械的等同性，CDP应重申并细化计划如何利用这些等同器械的临床数据（包括已发表文献、上市后数据等）来支持待评价器械的临床评价。

上市前新临床研究的规划（如适用）

若通过对现有数据的全面评估后，发现尚不足以完全覆盖所有临床宣称、解决所有已识别的临床风险，或充分证明器械符合所有相关的GSPR，则CDP必须清晰阐述任何计划在上市前开展的新临床研究。

对于每一项计划中的上市前临床研究，CEP中的CDP部分应提供一个概要性描述（更详细的内容通常包含在专门的临床研究方案（CIP）和研究者手册（IB）中），至少应涵盖：

• 研究的基本原理和目标： 清晰说明该研究旨在解决哪些具体问题，或验证哪些特定的安全性和/或性能宣称。
• 研究设计概览： 例如，是探索性研究、可行性研究、关键性（pivotal）研究，还是注册登记研究等。
• 主要终点指标： 概述与器械安全性和性能宣称直接相关的、计划在研究中进行评估的主要临床结果。
• 目标受试人群和样本量考量： 简要说明研究拟纳入的受试者特征及大致的样本规模估算依据。
• 预期的时间节点与里程碑： 给出研究计划的主要时间安排。
• 合规性声明： 确认研究将遵循适用的法规要求（如MDR）、伦理原则以及相关标准（如ISO 14155）。

如果经过评估，现有数据被认为足以支持上市前的临床评价，无需新的上市前临床研究，CDP则必须提供充分且有力的论证来支持这一结论。

上市后临床跟踪 (PMCF) 的前瞻性规划

CDP不能仅局限于上市前的活动，它必须展现一个覆盖器械整个生命周期的临床数据收集情况，其中上市后临床跟踪（PMCF）是不可或缺的一环。PMCF旨在持续确认器械的临床安全性和性能，并在真实世界使用中监测其长期表现。

在CEP的CDP章节中，应概述PMCF的初步规划和策略方向。并且应当与器械的风险、特性以及在上市前临床评价时尚存的任何不确定性相适应。可以提及计划采用的PMCF活动类型，例如：

• 对常规上市后监测（PMS）数据的持续分析（包括用户投诉、警戒报告、使用趋势分析等）。
• 定期的系统性文献追踪和回顾。
• 通过用户反馈调查、患者报告结局（PROs） 等方式收集信息。
• 建立或参与产品注册登记研究。
• 开展特定的PMCF研究（例如，观察性研究、扩展队列研究，甚至是上市后对照研究，以解决特定的长期安全性和性能问题，或进一步验证在不同亚组人群中的表现）。

CDP中应阐明PMCF活动的主要目的，通常包括：

• 持续确认器械在其预期使用寿命内的临床安全性和性能表现。
• 识别和分析任何先前未知的潜在风险、副作用或并发症。
• 监测与该器械相关的当前技术发展水平（SOTA）的演变。
• 持续确认器械的受益风险比是否保持在可接受的范围内。

CDP与临床评价总体目标的关联

整个CDP的叙述应清晰地将其各项计划活动（无论是上市前还是上市后）与临床评价的根本目标紧密联系起来。即，这些活动是如何共同作用，以收集充分的临床证据来证明器械符合相关的GSPR、确认其受益风险判定，并科学地支持其各项临床宣称。同时，CDP的执行结果也将为风险管理过程的持续更新和临床评价报告的定期更新提供关键输入。

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Within the Clinical Evaluation Plan (CEP), the “Clinical Development Plan (CDP)” chapter serves as a strategic blueprint, clearly outlining the series of activities planned by the manufacturer to gather and evaluate clinical evidence. This evidence is necessary to demonstrate the conformity of the device under evaluation with the relevant General Safety and Performance Requirements (GSPRs) and to confirm its benefit-risk profile throughout its entire lifecycle. This chapter should present a logically sequenced and phased strategy, progressing from the assessment of existing data, through any necessary new clinical investigations (if required), to post-market clinical follow-up (PMCF). The level of detail should be proportionate to the device’s risk class, novelty, the adequacy of existing knowledge, and relevant regulatory requirements (such as MDR Annex XIV Part A, section 1(a)).

This chapter is essential to demonstrate the manufacturer’s proactive planning and commitment to generating clinical evidence.

Defining the Current Stage and Overall Strategy of Clinical Development

Firstly, the CDP should concisely state the current stage of the device’s clinical development. For instance, it might be a newly designed device seeking initial CE marking, a significant modification of an existing marketed device, or an iteration of a product based on well-established technology. This contextual information directly influences the subsequent strategy for clinical evidence generation.

Building on this, an overview of the general strategy for obtaining and/or generating clinical evidence should be provided. This includes specifying how existing data is planned to be leveraged and, if existing data is insufficient to fully demonstrate safety and performance, how new clinical investigations will be conducted to address these gaps.

Plan for Integration and Utilization of Existing Clinical-Relevant Data

The CDP should detail the plan for systematically collecting, integrating, and evaluating existing clinical-relevant data. These data sources may include:

• Preclinical Study Data: This forms the basis for demonstrating the device’s conformity with its technical specifications and fundamental safety and performance requirements. An overview of key completed preclinical studies (e.g., bench testing, simulated use, animal studies) and how their main conclusions support the initial assessment of clinical safety and performance should be provided.
• Existing Published Literature Data: It should describe the plan for systematically searching, screening, and appraising scientific literature relevant to the device under evaluation itself (if such literature exists), or to similar or equivalent devices with comparable technological characteristics and intended uses.
• Data from Equivalent Devices (if applicable): If equivalence to one or more equivalent devices has been successfully demonstrated in preceding chapters of the CEP, the CDP should reiterate and elaborate on the plan to utilize clinical data from these equivalent devices (including published literature, post-market data, etc.) to support the clinical evaluation of the device under evaluation.

Planning for New Pre-Market Clinical Investigations (if applicable)

If, after a comprehensive assessment of existing data, it is determined that this data is insufficient to fully cover all clinical claims, address all identified clinical risks, or adequately demonstrate conformity with all relevant GSPRs, then the CDP must clearly articulate any new pre-market clinical investigations planned.

For each planned pre-market clinical investigation, the CDP section of the CEP should provide a summary description (more detailed information is typically contained in dedicated Clinical Investigation Plans (CIPs) and Investigator’s Brochures (IBs)), covering at least:

• Rationale and Objectives of the Investigation: Clearly state the specific questions the investigation aims to answer or the specific safety and/or performance claims it intends to validate.
• Overview of Investigation Design: For example, whether it is an exploratory, feasibility, pivotal, or registry study.
• Primary Endpoints: Outline the main clinical outcomes directly related to the device’s safety and performance claims that are planned for assessment in the investigation.
• Target Population and Sample Size Considerations: Briefly describe the characteristics of the subjects to be enrolled and the basis for estimating the approximate sample size.
• Anticipated Timelines and Milestones: Provide a general schedule for the main phases of the investigation.
• Statement of Compliance: Confirm that the investigation will adhere to applicable regulatory requirements (e.g., MDR), ethical principles, and relevant standards (e.g., ISO 14155).

If, after evaluation, existing data is deemed sufficient to support the pre-market clinical evaluation without the need for new pre-market clinical investigations, the CDP must provide a robust and well-supported justification for this conclusion.

Proactive Planning for Post-Market Clinical Follow-up (PMCF)

The CDP must not be limited to pre-market activities; it must demonstrate a vision for clinical data collection that spans the entire lifecycle of the device, in which Post-Market Clinical Follow-up (PMCF) is an indispensable component. PMCF aims to continuously confirm the device’s clinical safety and performance and to monitor its long-term behavior in real-world use.

In the CDP chapter of the CEP, an outline of the initial PMCF plan and strategic direction should be provided. This should be proportionate to the device’s risks, characteristics, and any uncertainties remaining from the pre-market clinical evaluation. Types of planned PMCF activities that can be mentioned include:

• Continuous analysis of routine Post-Market Surveillance (PMS) data (including user complaints, vigilance reports, trend analysis).
• Regular systematic literature reviews and monitoring.
• Information gathering through user feedback surveys, Patient-Reported Outcomes (PROs), etc.
• Establishment of or participation in product registries.
• Conducting specific PMCF studies (e.g., observational studies, extended cohort studies, or even post-market controlled studies to address specific long-term safety and performance questions, or to further validate performance in different subgroups).

The CDP should articulate the main objectives of PMCF activities, which typically include:

• Continuously confirming the clinical safety and performance of the device throughout its expected lifetime.
• Identifying and analyzing any previously unknown potential risks, side-effects, or complications.
• Monitoring developments in the state-of-the-art (SOTA) relevant to the device.
• Continuously confirming that the device’s benefit-risk profile remains acceptable.

Linking the CDP to Overall Clinical Evaluation Goals

The entire narrative of the CDP should clearly connect its various planned activities (both pre-market and post-market) to the fundamental goals of the clinical evaluation. That is, how these activities collectively contribute to gathering sufficient clinical evidence to demonstrate conformity with relevant GSPRs, confirm the benefit-risk determination, and scientifically substantiate its clinical claims. Furthermore, the outcomes of the CDP activities will provide crucial input for the ongoing updates of the risk management process and the periodic updates of the Clinical Evaluation Report.

在临床评价计划（CEP）中，“临床评价范围”的核心任务是精确界定本次临床评价工作的边界、深度和焦点。一个清晰、周全的范围定义，能确保临床评价活动既全面覆盖所有法规要求和关键临床问题，又避免漫无目的地偏离核心目标，从而高效、准确地评估待评价医疗器械的安全性和性能。

本章节的内容旨在向所有相关方（包括内部团队、公告机构等）清晰传达评价将涵盖哪些内容、基于何种考量，以及将如何进行。

明确待评价器械及其核心背景

临床评价范围的界定，首先始于对核心评价对象的清晰识别。需要明确指出本次临床评价所针对的具体医疗器械名称，以及所覆盖的型号、规格或系列（如果适用）。

应阐明该器械当前的生命周期阶段。例如，是正在寻求初次CE认证的全新器械，还是对已上市器械的重大变更进行评估，或是对一个成熟的“遗留器械”按照MDR要求进行的再评价。不同的生命周期阶段，其评价的侧重点和所需证据的深度自然有所不同。

此外，若待评价器械包含任何需要特别关注的设计特征（例如，采用了创新材料、包含药物成分、动物或人体源性材料等）、特定的预期用途或适应症（例如，针对特定罕见病、或在特定高风险操作中使用），或面向特殊的目标患者人群（如儿童、孕妇、或免疫功能低下者），这些都必须在范围中明确，它们往往需要更具针对性的数据收集和风险评估策略。

阐明评价目标与核心宣称

评价范围的设定必须紧密围绕待评价器械的预期用途和制造商所提出的各项临床宣称。应清晰列出或概述这些关于器械安全性、临床性能、以及预期临床受益的关键宣称。

同时，范围部分应明确本次临床评价旨在证明器械符合哪些相关的通用安全和性能要求（GSPR），尤其是GSPR 1（关于器械达到预期目的且安全有效）和GSPR 8（关于临床评价的要求），以及其他与该器械类型和特性相关的GSPR条款。

界定数据来源的依赖程度与策略

临床评价范围需要清晰规划将依赖哪些数据来源，以及如何利用这些数据。

• 等同性路径的考量（如适用）： 如果计划通过与一个或多个已上市器械的“等同性”路径来进行临床评价，则本范围章节应再次确认这一策略。需要简要重申将哪些器械作为等同器械，并明确指出，对这一等同性主张的持续适宜性进行评估本身，也属于本次临床评价的范围之内。同时，应确认是否有足够的高质量临床数据可从这些等同器械获取，用以支持待评价器械的临床宣称。
• 当前技术发展水平（SOTA）的应用： 必须明确界定将如何确定和应用当前的技术发展水平（SOTA）作为评价的参照基准。这包括识别相关的临床状况及其自然病程、现有的标准治疗方法（涵盖其他标杆器械、替代治疗技术等），以及所有适用的国际/协调标准和行业指南文件。临床评价的一个重要方面就是将待评价器械的安全性和性能置于此SOTA背景下进行比较和衡量。
• 与风险管理的整合： 评价范围需明确阐述临床评价将如何系统地处理在风险管理过程中已识别的各项临床风险。核心在于通过临床数据来确认，在综合考量器械的预期受益和当前SOTA后，所有剩余风险是否均处于可接受的水平。此外，临床评价还致力于通过收集的临床证据来验证已知风险的实际发生率，或识别出先前未被发现的潜在新风险。
• 计划使用的数据类型与来源： 应概述在临床评价过程中，计划搜寻、筛选和纳入分析的具体数据类型。通常包括：
  • 临床前数据： 例如，制造商内部完成的台架测试、动物实验、生物相容性评估等，用以支持器械的基本安全、性能和对相关标准的符合性。
  • 已发表的科学文献： 关于待评价器械本身（若有）或类似/等同器械的临床研究、病例报告、系统综述等。
  • 临床研究数据： 若有正在进行或已完成的针对待评价器械的临床研究，其数据是核心证据。
  • 上市后监测（PMS）数据： 包括用户投诉、不良事件报告、警戒数据、文献监测、用户反馈等。
  • 不良事件数据库信息： 从各国监管机构或专业数据库中获取的与同类器械相关的不良事件报告。

应对变更与新出现的临床考量

临床评价范围的设定还需具备前瞻性和适应性。

• 如果待评价器械在其设计、制造工艺、预期用途、标签或使用说明等方面，较之先前版本（如有）或在开发过程中发生了任何相关变更，评价范围必须包含对这些变更可能带来的临床影响进行评估。对于全新器械，则重点在于其创新特性所带来的特定评估需求。
• 评价范围还应覆盖一个持续的过程，即主动识别和评估任何与该器械、其同类产品或相关技术相关的新出现的临床安全或性能问题。这些信息可能来源于最新的科学文献、监管机构的警示、专业学会的意见，或通过PMS活动获得。

与上市后监测（PMS）活动的衔接

临床评价并非一次性活动，其结果与上市后监测（PMS）及上市后临床跟踪（PMCF）紧密相连。因此，评价范围应考虑：

• 本次临床评价的结论将如何为正在进行的PMS活动（特别是PMCF计划的制定或调整）提供输入和指导。
• 未来的临床评价报告（CER）更新将如何系统地纳入新的PMS数据、PMCF结果以及SOTA的任何变化，以确保临床评价的持续有效性和及时性。

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Within the Clinical Evaluation Plan (CEP), the “Clinical Evaluation Scope” chapter is to precisely define the boundaries, depth, and focus of the current clinical evaluation activities. A clear and comprehensive scope definition ensures that the clinical evaluation comprehensively covers all regulatory requirements and key clinical questions, while also preventing it from becoming overly broad or deviating from its central objectives. This approach facilitates an efficient and accurate assessment of the safety and performance of the device under evaluation.

The drafting of this chapter should aim to clearly communicate to all relevant parties (including internal teams, Notified Bodies, etc.) what the evaluation will encompass, based on what considerations, and how it will be conducted.

Defining the Device Under Evaluation and Its Core Context

The definition of the clinical evaluation scope begins with a clear identification of the core subject of the evaluation. The specific name of the medical device targeted by this clinical evaluation, along with the models, sizes, or series it covers (if applicable), needs to be explicitly stated.

Subsequently, the device’s current lifecycle stage should be elucidated. For instance, whether it is a new device seeking initial CE marking, an evaluation of a significant change to a marketed device, or a re-evaluation of a mature “legacy device” according to MDR requirements. Different lifecycle stages naturally entail different emphases in the evaluation and varying depths of required evidence.

Furthermore, if the device under evaluation incorporates any design features requiring special attention (e.g., use of innovative materials, inclusion of medicinal substances, materials of animal or human origin), specific intended uses or indications (e.g., for a rare disease, or use in a specific high-risk procedure), or is intended for particular target patient populations (such as children, pregnant women, or immunocompromised individuals), these must be highlighted within the scope. Such aspects often necessitate more targeted data collection and risk assessment strategies.

Articulating Evaluation Objectives and Key Claims

The scope of the evaluation must be closely aligned with the intended use of the device under evaluation and the various clinical claims made by the manufacturer. These key claims regarding the device’s safety, clinical performance, and intended clinical benefits should be clearly listed or summarized.

Concurrently, the scope section should specify which relevant General Safety and Performance Requirements (GSPRs) this clinical evaluation aims to demonstrate conformity with, particularly GSPR 1 (regarding the device achieving its intended purpose and being safe and effective) and GSPR 8 (regarding clinical evaluation requirements), as well as other GSPRs relevant to the device type and characteristics.

Defining the Extent of Reliance on Data Sources and Strategy

The scope of the clinical evaluation needs to clearly map out which data sources will be relied upon and how this data will be utilized.

• Consideration of the Equivalence Pathway (if applicable): If the clinical evaluation plans to follow an “equivalence” pathway with one or more marketed devices, this scope section should reaffirm this strategy. It needs to briefly reiterate which device(s) are considered equivalent and explicitly state that assessing the continued appropriateness of this equivalence claim itself falls within the scope of this clinical evaluation. Additionally, it should confirm whether sufficient high-quality clinical data is available from these equivalent device(s) to support the clinical claims for the device under evaluation.
• Application of State-of-the-Art (SOTA): It must be clearly defined how the current state-of-the-art (SOTA) will be established and applied as a benchmark for the evaluation. This includes identifying relevant clinical conditions and their natural course, existing standard treatment modalities (covering other benchmark devices, alternative therapeutic technologies, etc.), and all applicable international/harmonized standards and industry guidance documents. A significant aspect of the clinical evaluation is to compare and measure the safety and performance of the device under evaluation against this SOTA backdrop.
• Integration with Risk Management: The scope needs to explicitly describe how the clinical evaluation will systematically address the various clinical risks identified during the risk management process. The core is to confirm, through clinical data, that all residual risks are at an acceptable level when considering the device’s intended benefits and the current SOTA. Furthermore, the clinical evaluation also aims to verify the actual incidence rates of known risks or to identify potential new risks not previously discovered, using the collected clinical evidence.
• Planned Data Types and Sources: An overview of the specific types of data planned for retrieval, screening, and inclusion in the analysis during the clinical evaluation should be provided. It includes:
  • Preclinical data: E.g., manufacturer’s internal bench testing, animal studies, biocompatibility assessments, supporting the device’s basic safety, performance, and conformity to relevant standards.
  • Published scientific literature: Clinical studies, case reports, systematic reviews, etc., concerning the device under evaluation itself (if available) or similar/equivalent devices.
  • Clinical investigation data: If clinical investigations are ongoing or have been completed for the device under evaluation, their data will naturally be core evidence.
  • Post-Market Surveillance (PMS) data: Including user complaints, adverse event reports, vigilance data, literature monitoring, user feedback, etc.
  • Adverse event database information: Adverse event reports related to similar types of devices obtained from national regulatory agency databases or specialized professional databases.

Addressing Changes and Newly Emerging Clinical Considerations

The definition of the clinical evaluation scope also needs to be forward-looking and adaptable.

• If the device under evaluation has undergone any relevant changes in its design, manufacturing process, intended use, labeling, or instructions for use compared to previous versions (if any) or during its development, the scope must include an assessment of the potential clinical impact of these changes. For a completely new device, the focus will be on the specific evaluation needs arising from its innovative features.
• The scope should also encompass an ongoing process to actively identify and evaluate any newly emerging clinical safety or performance concerns related to the device, its analogues, or associated technologies. This information may originate from the latest scientific literature, warnings from regulatory authorities, opinions from professional societies, or be captured through PMS activities.

Linkage with Post-Market Surveillance (PMS) Activities

Clinical evaluation is not a one-time event; its findings are closely linked with Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Therefore, the scope should consider:

• How the conclusions of this clinical evaluation will provide input and guidance for ongoing PMS activities (particularly the development or adjustment of the PMCF plan).
• How future Clinical Evaluation Report (CER) updates will systematically incorporate new PMS data, PMCF results, and any evolution in the SOTA to ensure the continued validity and timeliness of the clinical evaluation.

在临床评价计划（CEP）中，本章节的核心任务是清晰、扼要地概述那些由制造商直接产生、持有或有权直接获取的，并将作为临床评价关键证据的数据。这部分内容旨在向监管机构展示制造商为支持其医疗器械安全性、性能和合规性已开展的工作和积累的内部证据基础。它构成了临床评价数据的重要组成部分，并为后续的数据分析和结论的得出提供了坚实的起点。

撰写本章节时，应侧重于对现有内部数据的盘点和总结，确保信息的准确性和可追溯性。

临床前研究数据的总结

临床前研究数据是奠定器械安全性和功能性基础的关键。CEP中应概述这些已完成的研究及其主要结论。

• 首先，应确认待评价器械在设计和制造过程中对相关产品标准（例如，特定的协调标准或行业标准）的符合性。
• 然后，需总结已执行的各项验证和确认（V&V）活动的结果。包括那些旨在证明器械设计输出满足设计输入要求，并且其设计足以支持预期临床用途的台架测试、性能测试、机械完整性测试、电气安全测试、以及软件验证等。应概括性地说明这些测试的结果如何证实了器械的功能性和安全性。
• 生物相容性评估应简述为待评价器械（特别是与人体直接或间接接触的部件）所进行的生物相容性评估的范围和结论，通常需声明评估是依据ISO 10993系列等相关标准进行的。可以提及支持性文件（如具体测试报告和生物学评估报告）。
• 若为待评价器械开展了临床前动物实验，则应概述这些研究的目的（例如，评估器械在体内的急性和/或慢性反应、初步的安全性和有效性等）、采用的动物模型、关键的观察指标及主要研究结果。
• 对于所有提及的临床前研究，CEP中只需提供结论性摘要，并应明确指出详细的研究报告和数据将在临床评价报告（CER）中进行更全面的呈现和分析。

制造商申办的临床研究数据总结（如有）

如果制造商已经或正在申办任何针对待评价器械的临床研究（无论是已完成、正在进行中，或是已初步规划且有部分数据可用的研究），本章节应提供相关概要信息。

• 对于每项研究，简要说明其当前状态（例如，已完成、数据分析中、受试者招募中等）。
• 如果已有初步或最终的研究结果，应概述与器械安全性和性能相关的主要发现和结论。
• 同样，应告知完整的临床研究报告将在CER中进行详细审阅。

上市后临床跟踪（PMCF）及上市后监测（PMS）数据的总结（如适用）

如果待评价器械（或其同一制造商的极相似前代产品）已在任何市场（包括欧盟以外地区）有销售和使用历史，本章节应总结通过PMS和PMCF活动收集到的相关数据。

• 可首先概述其市场应用的概况，例如已上市的地区、销售数量或大致的临床应用例数、以及市场应用的持续时间等。
• 然后，应总结从这些实际应用中收集到的安全性数据，例如收到的用户投诉类型和数量、发生的不良事件报告（包括严重程度和频次）、以及任何相关的警戒活动或纠正/预防措施。如果数据量较大或细节繁多，可以采用表格形式进行归纳，并在CEP中呈现关键趋势或总结性发现。
• 如果已开展并完成了特定的PMCF研究或活动（如前述PMCF调查、注册登记研究分析等），其主要结果也应在此概述。
• 若待评价器械为全新产品，尚无市场应用历史，则应明确说明当前无此类数据，但可同时指出制造商已建立了上市后监测和临床跟踪的程序和计划，将在器械上市后按计划收集和分析相关数据。

关于文献检索数据的定位说明

本章节的核心在于总结由“制造商产生和持有”的数据。而关于通过系统性文献检索获取的数据，其详细的检索策略、数据库列表、检索词、纳入/排除标准、文献筛选流程以及质量评估方法等，应在CEP的方法学部分（文献检索方案）中进行详细阐述。

本章节（制造商产生和持有的数据总结）主要聚焦于源自制造商自身研发、测试、生产和上市后监控活动所直接产生的数据。如果制造商为其特定器械或同系列产品维护了一个内部的、已整理和评估过的相关科学文献数据库或知识库，作为其持有的重要信息资源，可以在此提及这一资源的存在及其在临床评价中的作用。

数据的可获取性与可追溯性

在总结上述各类数据时，CEP应传递一个明确信息：所有提及的由制造商产生和持有的数据均有相应的原始记录和报告作为支撑，并将在后续的临床评价报告（CER）中进行详细的引用、分析和评估。

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Within the Clinical Evaluation Plan (CEP), the core objective of this chapter is to clearly and concisely outline the data that has been directly generated, is held by, or is directly accessible to the manufacturer, and which will serve as critical evidence in the clinical evaluation. This section aims to showcase to authorities the existing internal evidence base accumulated through the manufacturer’s activities in support of the medical device’s safety, performance, and conformity. It constitutes a significant component of the clinical evaluation data and provides a solid starting point for subsequent data analysis and conclusion drawing.

When drafting this chapter, the focus should be on inventorying and summarizing existing internal data, ensuring the accuracy and traceability of the information.

Summary of Preclinical Study Data

Preclinical study data is fundamental to establishing the safety and functional basis of the device. The CEP should provide an overview of these completed studies and their main conclusions.

• Firstly, conformity of the device under evaluation with relevant product standards (e.g., specific harmonized or industry standards) during its design and manufacture should be confirmed.
• Next, a summary of the results from executed Verification and Validation (V&V) activities is required. This includes bench tests, performance tests, mechanical integrity tests, electrical safety tests (if applicable), and software validation (if applicable) aimed at demonstrating that the device design output meets design input requirements and that its design is adequate for the intended clinical use. It should be generally stated how the results of these tests confirm the device’s functionality and safety.
• Biocompatibility assessment is a critically important aspect. A brief overview of the scope and conclusions of biocompatibility assessments conducted for the device under evaluation (particularly for parts in direct or indirect contact with the human body) should be provided, typically stating that assessments were performed according to relevant standards such as the ISO 10993 series. It can be mentioned that supporting documentation (like specific test reports and biological evaluation reports) is available in the technical documentation for review.
• If preclinical animal studies were conducted for the device under evaluation, an overview of the objectives of these studies (e.g., to assess acute and/or chronic in-vivo responses, preliminary safety and efficacy), the animal models used, key observation parameters, and principal study outcomes should be provided.
• For all mentioned preclinical studies, the CEP need only provide conclusive summaries, and it should be clearly stated that detailed study reports and data will be presented and analyzed more comprehensively in the Clinical Evaluation Report (CER).

Summary of Manufacturer-Sponsored Clinical Investigation Data (if any)

If the manufacturer has sponsored or is sponsoring any clinical investigations for the device under evaluation (whether completed, ongoing, or in early planning stages with some data available), this section should provide relevant summary information.

• For each study, briefly state its current status (e.g., completed, data analysis in progress, subject recruitment ongoing).
• If preliminary or final study results are available, outline the main findings and conclusions related to device safety and performance.
• Similarly, it should be indicated that full clinical study reports will be reviewed in detail in the CER.

Summary of Post-Market Surveillance (PMS) and PMCF Data (if applicable)

If the device under evaluation (or a very similar predecessor model from the same manufacturer) has a history of being marketed and used in any region (including outside the EU), this section should summarize the relevant data collected through PMS and PMCF activities.

• An overview of its market application can be provided first, such as regions where it is marketed, sales volume or approximate number of clinical applications, and duration of market presence.
• Subsequently, safety data collected from these real-world applications should be summarized, such as the types and numbers of user complaints received, adverse event reports (including severity and frequency), and any related vigilance activities or corrective/preventive actions. If the volume of data or level of detail is extensive, a tabular format can be used for summarization, presenting key trends or summary findings in the CEP.
• If specific PMCF studies or activities (like the aforementioned PMCF survey, registry study analyses, etc.) have been conducted and completed, their main results should also be outlined here.
• If the device under evaluation is entirely new and has no market history, this should be clearly stated. However, it can also be mentioned that the manufacturer has established procedures and plans for post-market surveillance and clinical follow-up, which will be implemented to collect and analyze relevant data after the device is launched.

Clarification on the Positioning of Literature Search Data

It is important to note that the core focus of this chapter is to summarize data “generated and held by the manufacturer.” Regarding data obtained through systematic literature searches, the detailed search strategy, list of databases, search terms, inclusion/exclusion criteria, literature screening process, and quality assessment methods should typically be detailed in the methodology section of the CEP (A dedicated literature search protocol).

This chapter (“Summary of Data Generated and Held by the Manufacturer”) primarily focuses on data directly resulting from the manufacturer’s own R&D, testing, manufacturing, and post-market monitoring activities. If the manufacturer maintains an internal, curated library or database of relevant scientific literature specifically for the device or device family, its existence as a significant information resource held by the manufacturer and its role in the clinical evaluation could be mentioned at a high level here.

Data Accessibility and Traceability

When summarizing these various types of data, the CEP should convey a clear message: all mentioned data generated and held by the manufacturer is supported by corresponding original records and reports. These documents will be available for detailed reference, analysis, and assessment in the subsequent Clinical Evaluation Report (CER).

在临床评价计划（CEP）中，“相关数据的评估与分析”的内容是阐述方法学的核心部分。它旨在清晰、系统地规划在临床评价过程中，将如何识别所有与待评价医疗器械相关的关键数据，如何严格评估这些数据的适用性、质量和科学有效性，以及最终如何综合分析这些经过评估的数据，以得出关于器械安全性、性能和受益风险比的结论。本章节所描述的计划和方法，是确保整个临床评价过程科学、客观、可重复并符合法规要求的关键。

撰写本章节时，应重点突出评估与分析过程的系统性、客观性和预设标准。

明确“相关数据”的范畴及识别策略

首先，CEP需要清晰界定对于本次临床评价而言，哪些数据被视为“相关数据 (pertinent data)”。这一定义应紧密围绕先前章节已明确的临床评价范围、待评价器械的特性、预期用途以及需要通过临床证据支持的具体宣称。

在此基础上，应简要重申计划从哪些主要途径获取这些相关数据。正如在CEP其他部分（如“制造商持有数据”、“文献检索策略”等）已有所提及，这些数据来源通常包括（但不限于）：

• 由制造商产生和持有的临床前数据（如台架测试、动物实验、生物相容性数据等）；
• 针对待评价器械或等同/类似器械的已发表科学文献；
• 制造商申办的临床研究数据（如有）；
• 上市后监测（PMS）和上市后临床跟踪（PMCF）数据；
• 来自等同器械的临床数据（如适用）；
• 风险管理过程的输出。

本章节应概述识别所有这些相关数据的具体策略和方法，特别是对于文献数据，应提及将采用系统性的文献检索和筛选方法。明确的纳入和排除标准对于确保数据筛选的客观性和一致性至关重要，应在此处概述或引用。

规划数据的评估过程 (Data Appraisal)

数据评估是临床评价的核心步骤之一，旨在判断所识别数据的质量及其对评价结论的贡献程度。CEP必须详细规划这一评估过程。

预设的评估标准： 强调将采用一套预先定义的、客观的评估标准来系统地评价所有收集到的数据。这些标准应确保评估过程的透明性和一致性，并尽可能减少偏倚。评估标准通常会覆盖以下几个维度：

• 相关性 (Relevance)： 评估数据是否直接关联到待评价器械（或其等同/类似器械）、其预期用途、目标人群、以及需要评价的特定安全性和性能终点。
• 质量与方法学可靠性 (Quality and Methodological Soundness)： 深入考察数据的产生方法，包括研究设计（如随机对照试验、观察性研究、病例系列等）、实施过程、数据收集的完整性、统计分析的适当性，以及潜在的偏倚来源（如选择偏倚、信息偏倚、混杂因素等）、随机误差的影响、信息披露的充分性等。
• 对符合性论证的贡献度 (Contribution to Demonstration of Conformity)： 根据数据的相关性和质量，判断其在证明器械安全性和性能方面的权重和价值。

评估标准的统一应用： 强调这些预设标准将统一应用于所有来源的数据（包括制造商持有的数据、文献数据、临床研究数据等），并且对正面（支持性）和负面（不支持或提示风险）的数据都将给予同等权重的客观评估。

数据的差异化使用： 认识到并非所有数据都能同等适用于所有评价目的。例如，某些研究设计上存在缺陷、不足以证明器械性能的数据，可能仍包含对安全性分析有价值的信息，反之亦然。CEP应说明在评估时会考虑这种差异化的适用性。

规划数据的分析策略 (Data Analysis)

在数据经过严格评估并被认为适用后，CEP必须规划如何对这些数据进行综合分析，以形成关于器械安全性、性能和受益风险的整体结论。

• 证据的综合与整合： 说明计划如何将来自不同来源（如临床前、临床研究、文献、PMS等）的、经过评估的证据进行系统性地整合与综合，以构建一个全面、连贯的证据体系。
• 临床证据缺口的识别与处理： 阐述在数据分析过程中，将如何识别临床证据中可能存在的缺口（即某些方面的安全或性能未能得到充分数据支持）或不同数据来源之间的不一致性。同时，应说明计划如何应对这些情况，例如，通过调整PMCF计划来进一步收集数据、在风险管理中重新评估相关风险，或在结论中明确承认存在的局限性。
• 受益风险分析： 这是数据分析的最终目标之一。CEP应明确指出数据分析将导向对待评价器械受益风险特征的全面评估，并结合当前技术发展水平（SOTA）和可替代治疗方案，判断其受益风险比是否可接受。
• 与通用安全和性能要求（GSPR）的符合性论证： 数据分析的计划应直接指向证明器械符合MDR中相关GSPR（特别是GSPR 1和GSPR 8）的要求。

临床证据水平的合理性论证

根据MDR法规第61条的要求，制造商必须明确并论证为证明其器械符合相关GSPR所必需的临床证据水平。CEP的本部分应前瞻性地阐述这一点。

声明证据水平： 清晰说明根据待评价器械的特性（如创新性、风险等级、技术成熟度等）及其预期用途，制造商认为何种水平和类型的临床证据是充分且适当的。

论证理由： 提供支持这一证据水平判断的详细理由。例如，对于成熟技术、低风险器械，可能更多依赖文献数据和临床前数据；而对于高风险或创新器械，则可能需要专门的上市前临床研究数据。

评价目标概述： 可以概述本次临床评价旨在通过所规划的证据水平来确认哪些具体方面，例如：

• 器械是否按制造商的预期和规定发挥性能。
• 器械的风险特征是否与可比器械或当前SOTA相当。
• 器械对于患者和使用者是否安全。
• 器械的整体受益风险比是否可接受。

过程的迭代性与最终报告

应明确数据评估和分析过程可能具有迭代性。在评估过程中发现的新信息或提出的新问题，可能需要调整临床评价的范围、优化计划，甚至补充额外的数据收集和分析工作。

最后，CEP应简要说明，所有相关数据的识别、筛选、评估、分析过程及其最终结论都将被完整、透明地记录在临床评价报告（CER）中。CER将基于这些分析，全面阐述器械的安全性、临床性能、临床受益，并就是否已获得充分的临床证据来支持器械的预期用途和符合性做出最终判断。

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Within the Clinical Evaluation Plan (CEP), the “Appraisal and Analysis of Pertinent Data” contents are core methodological information. It aims to clearly and systematically plan how all pertinent clinical data related to the device under evaluation will be identified during the clinical evaluation process, how the suitability, quality, and scientific validity of this data will be rigorously assessed, and finally, how this appraised data will be collectively analyzed to draw conclusions regarding the device’s safety, performance, and benefit-risk profile. The plans and methods described in this chapter are key to ensuring that the entire clinical evaluation process is scientific, objective, repeatable, and compliant with regulatory requirements.

When drafting this chapter, the emphasis should be on the systematic nature, objectivity, and pre-defined criteria of the appraisal and analysis process.

Defining the Scope of “Pertinent Data” and Identification Strategy

Firstly, the CEP needs to clearly define what constitutes “pertinent data” for this specific clinical evaluation, closely aligning with the previously established clinical evaluation scope, the characteristics of the device under evaluation, its intended use, and the specific claims that need to be supported by clinical evidence.

Building on this, a brief reiteration of the main pathways planned for acquiring this pertinent data should be provided. As mentioned in other parts of the CEP (such as “Data Generated and Held by the Manufacturer,” “Literature Search Strategy,” etc.), these data sources typically include (but are not limited to):

• Preclinical data generated and held by the manufacturer (e.g., bench testing, animal studies, biocompatibility data).
• Published scientific literature pertaining to the device under evaluation or equivalent/similar devices.
• Data from manufacturer-sponsored clinical investigations (if any).
• Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data.
• Clinical data from equivalent devices (if applicable).
• Outputs from the risk management process.

This part should outline the specific strategy and methods for identifying all such pertinent data. Particularly for literature data, it should mention that systematic literature search and screening methodologies will be employed. Clear inclusion and exclusion criteria are crucial for ensuring the objectivity and consistency of data screening and should be outlined or referenced here.

Planning the Data Appraisal Process

Data appraisal is one of the core steps of clinical evaluation, aimed at judging the quality of the identified data and its contribution to the evaluation conclusions. The CEP must detail this appraisal process.

Pre-defined Appraisal Criteria: Emphasize that a pre-defined, objective set of appraisal criteria will be used to systematically evaluate all collected data. These criteria should ensure the transparency and consistency of the appraisal process and minimize bias as much as possible. Appraisal criteria typically cover the following dimensions:

• Relevance: Assessing whether the data directly pertains to the device under evaluation (or its equivalent/similar devices), its intended use, target population, and the specific safety and performance endpoints under evaluation.
• Quality and Methodological Soundness: Thoroughly examining the methods used to generate the data, including study design (e.g., randomized controlled trials, observational studies, case series), conduct, completeness of data collection, appropriateness of statistical analysis, and potential sources of bias (e.g., selection bias, information bias, confounding factors), the impact of random error, adequacy of information disclosure, etc.
• Contribution to Demonstration of Conformity: Based on the relevance and quality of the data, judging its weight and value in demonstrating the safety and performance of the device.

Uniform Application of Appraisal Criteria: Stress that these pre-defined criteria will be uniformly applied to all data sources (including manufacturer-held data, literature data, clinical investigation data, etc.), and that both favorable (supportive) and unfavorable (non-supportive or indicative of risk) data will be objectively appraised with equal weight.

Differential Use of Data: Recognize that not all data may be equally suitable for all evaluation purposes. For instance, data from studies with design flaws that are insufficient to demonstrate device performance might still contain information valuable for safety analysis, and vice versa. The CEP should state that this differential applicability will be considered during appraisal.

Planning the Data Analysis Strategy

Once data has been rigorously appraised and deemed suitable, the CEP must plan how this data will be collectively analyzed to form overall conclusions about the device’s safety, performance, and benefit-risk profile.

• Evidence Synthesis and Integration: Explain how appraised evidence from various sources (e.g., preclinical, clinical investigations, literature, PMS) will be systematically integrated and synthesized to build a comprehensive and coherent body of evidence.
• Identification and Handling of Clinical Evidence Gaps: Describe how, during data analysis, any potential gaps in clinical evidence (i.e., certain aspects of safety or performance not adequately supported by data) or inconsistencies between different data sources will be identified. Also, outline the planned approach to address these situations, for example, by adjusting PMCF plans to gather further data, reassessing relevant risks in risk management, or clearly acknowledging limitations in the conclusions.
• Benefit-Risk Analysis: This is one of the ultimate goals of data analysis. The CEP should clearly state that the data analysis will lead to a comprehensive assessment of the benefit-risk profile of the device under evaluation, and whether this profile is acceptable when considered against the current state-of-the-art (SOTA) and available alternative treatments.
• Demonstration of Conformity with General Safety and Performance Requirements (GSPRs): The data analysis plan should be directly aimed at demonstrating the device’s conformity with the relevant GSPRs of the MDR (particularly GSPR 1 and GSPR 8).

Justification for the Level of Clinical Evidence

As per MDR Article 61, the manufacturer must specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant GSPRs for their device. This part of the CEP should prospectively address this.

Declaration of Evidence Level: Clearly state what level and type of clinical evidence is considered sufficient and appropriate by the manufacturer, based on the characteristics of the device under evaluation (e.g., novelty, risk class, technological maturity) and its intended use.

Rationale for Justification: Provide a detailed rationale supporting this judgment of evidence level. For example, for mature technology, low-risk devices, greater reliance might be placed on literature data and preclinical data; whereas for high-risk or innovative devices, dedicated pre-market clinical investigation data might be necessary.

Overview of Evaluation Objectives: An outline can be provided of what specific aspects this clinical evaluation aims to confirm through the planned level of evidence, for example:

• Whether the device performs as intended and specified by the manufacturer.
• Whether the risk profile of the device is comparable to that of similar devices or the current SOTA.
• Whether the device is safe for both patients and users.
• Whether the overall benefit-risk profile of the device is acceptable.

Iterative Nature of the Process and Final Reporting

It should be clarify that the data appraisal and analysis process can be iterative. New information discovered or new questions raised during the appraisal may necessitate adjustments to the clinical evaluation scope, refinements to the plan, or even supplementary data collection and analysis.

Finally, the CEP should briefly state that the complete process of identifying, screening, appraising, and analyzing all pertinent data, along with the final conclusions, will be fully and transparently documented in the Clinical Evaluation Report (CER). The CER will, based on these analyses, comprehensively describe the device’s safety, clinical performance, clinical benefits, and make a final judgment on whether sufficient clinical evidence has been obtained to support the device’s intended use and conformity.

在临床评价计划（CEP）中，清晰、系统地阐述文献检索的规划和方法至关重要。这部分内容，无论是在CEP正文中概述并在附录中详述，还是作为CEP的一个独立章节，其核心目的均是预先设定一个科学、严谨、可重复的流程，用以全面、客观地识别和获取与待评价医疗器械相关的已发表科学文献及安全性数据。一个周密的文献检索计划是确保临床评价所依赖的外部证据既充分又无偏倚的关键保障。

LSP节应清晰勾勒出从检索目标设定到最终文献筛选的完整策略。

明确文献检索的目标与范围

首先，需要明确本次文献检索旨在达成的核心目标。这些目标通常与临床评价的整体目的紧密相连，可能包括（但不限于）：

• 确立与待评价器械相关的医学领域、特定临床状况以及相关治疗技术的当前技术发展水平（State-of-the-Art, SOTA）。
• 搜集关于待评价器械本身（如果已有相关公开发表的研究或报告）的临床数据、安全性和性能信息。
• 识别并获取关于类似器械、基准器械或已确定的等同器械的临床数据，以便进行比较分析或支持等同性论证。
• 收集关于潜在的临床危害、不良事件、并发症以及与该类器械或技术相关的已知风险信息。

在明确目标之后，应界定文献检索的范围。这包括确定检索的时间跨度（例如，过去5年、10年，或根据技术发展速度和产品特性确定的特定时间窗口）、文献的语种（通常为英文），以及在检索过程中特别关注的器械特性、临床应用场景或患者亚群。

构建清晰的检索问题 (Research Questions)

为了使文献检索更具针对性和有效性，预先设定明确的检索问题是不可或缺的一步。这些问题应源自临床评价的核心目标、待评价器械的预期用途、关键临床宣称、以及在风险评估或现有数据回顾中发现的任何不确定性或信息缺口。

检索问题可以围绕不同主题进行组织，例如：

• 针对当前技术发展水平（SOTA）的检索问题：这类问题旨在全面了解相关疾病的治疗现状、主流技术、替代疗法及其各自的临床安全性和性能表现。
• 针对特定器械（包括待评价器械、类似/等同/基准器械）的检索问题：这类问题则更侧重于收集直接相关的临床证据，用以评估这些器械的具体安全性和性能，或进行横向比较。

制定周详的检索策略

检索策略是文献检索计划的核心，它详细规定了将如何系统地查找所需信息。

数据来源的选择： 必须明确计划检索哪些类型的数据库和信息来源。详见：文献来源及选择理由 和 临床数据的分析。

检索词与检索式的构建： 这是确保检索全面性和准确性的关键技术环节。应阐述选择和组合检索词的系统方法。

• 初步信息收集与理解： 在正式构建复杂的数据库检索式之前，进行广泛的初步信息调研是非常有帮助的。有助于全面理解相关的疾病背景、当前临床实践、权威指南推荐、关键的安全与性能评价指标以及尚未满足的医疗需求。这种初步探索（可利用通用搜索引擎如Google Scholar）为后续精准检索词的选择和优化奠定了基础。
• 核心检索词的选择与组合： 需要围绕待评价器械的特性（如通用名称、技术原理、关键组件）、预期用途（相关的疾病、适应症、手术过程）、目标人群、关注的临床结局（如安全性指标、性能指标、有效性指标）以及比较对象（如类似/等同器械的商品名、通用名）来系统地构建关键词表。
• 检索逻辑的运用： 说明将如何运用布尔逻辑运算符（AND, OR, NOT）、截词符、通配符以及字段限制（如标题、摘要、关键词字段）等技术来组合这些关键词，构建针对不同数据库语法的具体检索式（Search Strings）。
• 针对不同检索目标的策略调整： 针对SOTA、待评价器械、以及类似/等同/基准器械的检索，其检索词的侧重点和组合方式可能有所不同，应分别予以考虑和规划。

检索限制条件的应用： 明确是否计划以及如何应用特定的检索限制，例如出版日期范围、文献语言、研究类型（如RCTs, 系统综述等）。但需注意，在筛选安全性相关信息时，过度依赖研究类型过滤器可能会遗漏来自非传统研究（如病例报告、不良事件数据库）的重要信号，因此使用时需谨慎权衡。

文献的筛选与选择流程

在执行检索并获得初步结果后，CEP必须规划一个系统、透明的文献筛选流程，以准确识别出真正相关的文献。

• 纳入与排除标准 (Inclusion and Exclusion Criteria)： 强调必须预先制定清晰、具体的文献纳入和排除标准。这些标准应直接源于先前设定的检索问题和评价范围，并应用于文献筛选的各个阶段（如标题和摘要初筛、全文复筛）。
• 筛选过程的执行： 简要描述计划如何执行筛选过程。

详细说明见：文献选择过程、文献选择标准，以及文献评估标准。

数据提取与检索过程的文档化

CEP中还应简要提及，对于最终被纳入的文献，计划如何系统地提取与其相关的数据（例如，可以预先设计数据提取表格，明确需要提取的关键信息字段）。

整个文献检索过程：从数据库的选择、检索日期、实际使用的完整检索式、每个数据库的检索结果数量，到各筛选阶段的纳入/排除文献数量（在CER中以PRISMA流程图等形式呈现）——都将被完整记录下来。这种全面的文档化是确保文献检索过程透明、可重复、可审核的基础。

与数据评估的衔接

所有通过上述系统性文献检索过程所识别并筛选出的相关文献，都将进入下一个环节——即按照CEP中“相关数据的评估与分析”章节所规划的方法学，进行严格的数据评估（Appraisal）。

通过如此规划和阐述文献检索计划，能够确保临床评价所依赖的文献证据是通过一个系统、全面、无偏倚且可重复的过程获得的，从而为后续的数据评估、分析以及最终的临床评价结论提供高质量的输入。

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Within the Clinical Evaluation Plan (CEP), a clear and systematic articulation of the literature search plan (LSP) and methodology is of critical importance. This section, whether outlined in the main body of the CEP and detailed in an appendix or presented as a standalone chapter, has the core purpose of prospectively defining a scientific, rigorous, and reproducible process for comprehensively and objectively identifying and retrieving published scientific literature and safety data relevant to the device under evaluation. A well-thought-out Literature Search Protocol is a key safeguard for ensuring that the external evidence upon which the clinical evaluation relies is both sufficient and unbiased.

The LSP should clearly delineate the complete strategy, from defining search objectives to the final selection of literature.

Defining the Objectives and Scope of the Literature Search

The core objectives that the literature search aims to achieve must be clearly defined. These objectives typically align closely with the overall goals of the clinical evaluation and may include (but are not limited to):

• Establishing the current State-of-the-Art (SOTA) for the relevant medical field, device type, and specific clinical conditions.
• Gathering clinical data and safety/performance information on the device under evaluation itself (if any publicly available studies or reports exist).
• Identifying and obtaining clinical data on similar devices, benchmark devices, or identified equivalent devices for comparative analysis or to support claims of equivalence.
• Collecting information on potential clinical hazards, adverse events, complications, and known risks associated with this class of device or technology.

After clarifying the objectives, the scope of the literature search should be defined. This includes determining the time period for the search (e.g., the last 5 years, 10 years, or a specific window based on the pace of technological development and product characteristics), language preferences for literature (typically English-dominant), and any particular device characteristics, clinical application scenarios, or patient subgroups that will be prioritized during the search.

Formulating Clear Research Questions

To make the literature search more targeted and effective, prospectively defining clear research questions is an indispensable step. These questions should stem from the core objectives of the clinical evaluation, the intended use of the device under evaluation, its key clinical claims, and any uncertainties or information gaps identified during risk assessment or review of existing data.

Research questions can be organized around different themes, such as:

• Research questions for the State-of-the-Art (SOTA): These questions aim to comprehensively understand the current treatment landscape for the relevant disease, mainstream technologies, alternative therapies, and their respective clinical safety and performance profiles.
• Research questions for device-specific searches (including the device under evaluation, similar/equivalent/benchmark devices): These questions are more focused on gathering directly relevant clinical evidence to assess the specific safety and performance of these devices or to conduct head-to-head comparisons.

Developing a Comprehensive Search Strategy

The search strategy is the heart of the Literature Search Protocol, detailing how the required information will be systematically sought.

Selection of Data Sources: The types of databases and information sources to be searched must be clearly specified.

Development of Search Terms and Search Strings: This is a critical technical aspect for ensuring the comprehensiveness and accuracy of the search. A systematic approach to selecting and combining search terms should be described.

• Foundational Information Gathering: Conducting broad preliminary information gathering before constructing complex database search strings is highly beneficial. This helps to comprehensively understand the relevant disease context, current clinical practices, authoritative guideline recommendations, key safety and performance evaluation metrics, and unmet medical needs. This initial exploration (which can utilize general search engines like Google Scholar) lays the foundation for the subsequent selection and optimization of precise search terms.
• Selection and Combination of Core Search Terms: A systematic list of keywords should be developed around the characteristics of the device under evaluation (e.g., generic name, technological principle, key components), its intended use (relevant diseases, indications, surgical procedures), target population, clinical outcomes of interest (e.g., safety indicators, performance indicators, efficacy indicators), and comparator devices (e.g., trade names, generic names of similar/equivalent devices).
• Application of Search Logic: Explain how Boolean operators (AND, OR, NOT), truncation symbols, wildcards, and field tags (e.g., title, abstract, keyword fields) will be used to combine these keywords into specific search strings adapted for the syntax of different databases.
• Tailoring Strategies for Different Search Objectives: The emphasis and combination of search terms may differ when searching for SOTA, the device under evaluation, or similar/equivalent/benchmark devices. These should be considered and planned separately.

Application of Search Limits and Filters: Specify if and how any particular search limits will be applied, such as publication date ranges, language of literature, or study types (e.g., RCTs, systematic reviews). However, caution is advised when using study type filters for safety-related searches, as important signals from non-traditional studies (like case reports, adverse event databases) might be missed.

Planning the Literature Screening and Selection Process

After executing the searches and obtaining initial results, the CEP must plan a systematic and transparent literature screening process to accurately identify truly relevant publications.

• Inclusion and Exclusion Criteria: Emphasize the necessity of pre-defining clear and specific criteria for including or excluding literature at each stage of screening (e.g., title and abstract review, full-text review). These criteria should be directly derived from the previously established research questions and evaluation scope.
• Execution of the Screening Process: Briefly describe how the screening process is planned to be carried out.

Data Extraction and Documentation of the Search Process

The CEP should also briefly mention the plan for systematically extracting relevant data from the finally included literature (e.g., a pre-designed data extraction form specifying key information fields can be developed).

The entire literature search process—from database selection, search dates, full search strings actually used, number of hits from each database, to the number of articles included/excluded at each screening stage (presented in the CER using a PRISMA flow diagram or similar)—will be fully and meticulously documented. Such comprehensive documentation is fundamental to ensuring the transparency, reproducibility, and auditability of the literature search process.

Linkage to Data Appraisal

All literature identified as pertinent through this systematic search process will proceed to the next step—rigorous data appraisal according to the methodology planned in the “Appraisal and Analysis of Pertinent Data” chapter of the CEP.

By planning and articulating the Literature Search Protocol in this manner, it ensures that the literature evidence relied upon for the clinical evaluation is obtained through a systematic, comprehensive, unbiased, and reproducible process, thereby providing high-quality input for subsequent data appraisal, analysis, and ultimately, the conclusions of the clinical evaluation.

数据收集报告（DCR）是临床评价过程中的一个关键文档，它系统地记录并总结了按照预定方案（通常是临床评价计划CEP中的文献检索计划LSP）执行数据检索活动的详细过程和直接产出。这份报告的核心目的是为后续的数据评估、分析以及最终临床评价报告（CER）的撰写，提供一个透明、可追溯、可审核的原始数据收集结果清单。

一份结构清晰、内容详实的DCR，通常会围绕以下几个核心方面展开。

1. DCR的目的、范围及基础信息

首先应明确阐述本DCR的目的与范围。包括清晰说明本报告旨在记录针对特定待评价医疗器械（应在此处简要列出器械的关键识别信息，如通用名称、预期用途、适应症、目标患者人群等）的安全性与性能评价，而进行的相关公开数据（主要来自科学临床文献和安全数据库）的收集、筛选和初步评估过程及其结果。应明确指出本次数据收集活动是严格依据先前在临床评价计划（CEP）中制定的文献检索计划（LSP）来执行的，从而确立DCR与整体临床评价策略的一致性。

2. 检索的数据库、时间范围及任何计划偏离

DCR需详尽记录实际检索的数据库名称及其设定的检索时间段。这应分别列出用于检索科学临床文献的数据库（例如PubMed, Embase等）和用于检索安全性信息（如不良事件、召回等）的数据库（例如FDA MAUDE, 各国药监局数据库如Swissmedic, BfArM, MHRA, TGA等）。对于不同类型的检索（如SOTA检索、特定器械检索），其设定的时间跨度（例如，SOTA检索可能限定为近五年，而安全数据库检索可能无时间限制以捕获所有相关事件）及其理由（例如，技术的快速发展或全面捕获安全事件的需求）均应清晰说明。

为确保透明度和可审核性，任何在实际执行过程中对原文献检索计划（LSP）的偏离情况及其理由，都必须在本报告中明确记录。若无偏离，则应明确声明。

3. 检索与筛选标准的确认

尽管详细的检索词表和纳入/排除标准已在LSP中制定，DCR中通常会再次确认或简要重述在实际筛选过程中严格应用的核心纳入与排除标准。这有助于读者理解文献筛选的依据，例如，是否仅纳入同行评审的已发表研究、特定语言（如英语）、以及是否排除体外研究、动物实验、会议摘要、综述评论等。

4. 数据初步评估方法的简述

DCR还需简要回顾在数据筛选和初步整理阶段所采用的数据评估方法。可能包括用于评估文献与待评价器械及研究问题相关性的标准（例如，通过打分体系评估器械的匹配度、应用的匹配度、患者群体的匹配度、报告质量等），以及用于初步判断文献科学质量的标准。应说明这些评估标准是如何被一致地应用于所有被识别的文献的，以及任何预设的纳入阈值（例如，相关性评分达到某一分值以上才被纳入进一步分析）。

5. 文献检索的量化结果呈现

这是DCR的核心内容之一，即科学文献检索的具体执行结果。此部分应以清晰、结构化的方式呈现：

• 各数据库的检索详情： 针对每个检索的数据库，列出实际使用的完整检索式（search strings）以及通过该检索式获得的原始文献数量。
• 筛选流程总结： 汇总所有数据库检索到的文献总数，在去除重复文献后的数量，以及经过标题/摘要初筛和全文复筛后，最终被纳入和排除的文献数量。强烈推荐使用PRISMA流程图或类似的图表形式，直观展示从最初检索到最终纳入文献的完整筛选路径，包括在每个阶段因何种主要原因排除了多少文献。

6. 纳入文献的初步评估结果与数据提取概要

对于通过筛选并被初步判定为相关的文献，DCR需要展示其初步评估的结果。逐篇列出纳入文献的基本信息（如引文格式），并附上其在相关性评估和科学质量初步评估中的得分或评级，以及最终是否被确认纳入深入分析的决定。

DCR应概述从这些最终纳入的文献中提取关键数据的情况。这部分旨在展示已从每篇重要文献中提取了哪些与器械安全性、性能、研究设计、患者特征等相关的信息。通常也会采用结构化表格，针对每篇文献列出提取的关键数据点（例如，患者/受试者数量、临床安全结果、临床性能结果、研究设计、器械型号、研究地点、局限性、证据等级等）。

7. 排除文献清单

为确保筛选过程的完整性和透明度，DCR需要附上一份清单，列出经过全文阅读后被最终排除的文献及其明确的排除理由。

8. 安全数据库检索结果

最后，DCR还需专门呈现从各类安全数据库中检索到的结果。列出所检索的每个安全数据库的名称、检索日期、执行的具体查询条件（如器械名称、报告日期范围等），以及检索到的相关条目数量。如果检索到了具体的不良事件报告、召回信息等，可能还需要对这些信息进行初步的归类和总结。

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A Data Collection Report (DCR) is a key document in the clinical evaluation process. It systematically records and summarizes the detailed procedures and direct outputs of data retrieval activities, particularly those executed according to a predefined protocol (the Literature Search Protocol (LSP) referenced in the Clinical Evaluation Plan (CEP)). The core purpose of this report is to provide a transparent, traceable, and auditable list of the original data collection results, which will then serve as the basis for subsequent data appraisal, analysis, and the compilation of the final Clinical Evaluation Report (CER).

A well-structured and comprehensive DCR typically unfolds around the following core aspects.

1. Purpose, Scope, and Foundational Information of the DCR

The introductory part of the report should first clearly articulate the Purpose and Scope of this DCR. This includes a clear statement that the report aims to document the collection, screening, and initial assessment process and results of relevant public data (primarily from scientific clinical literature and safety databases) for the evaluation of the safety and performance of the specific medical device(s) under evaluation (key identifying information for the device, such as its generic name, intended use, indications, target patient population, etc., should be briefly listed here). It should be explicitly stated that this data collection activity was conducted in strict accordance with the Literature Search Protocol (LSP) previously established in the Clinical Evaluation Plan (CEP), thereby establishing the DCR’s consistency with the overall clinical evaluation strategy.

2. Databases Searched, Time Periods, and Any Deviations from Plan

The DCR must meticulously document the names of the databases actually searched and the search periods applied. This should separately list the databases used for retrieving scientific clinical literature (e.g., PubMed, Embase) and those used for retrieving safety information (e.g., adverse events, recalls, such as FDA MAUDE, national competent authority databases like Swissmedic, BfArM, MHRA, TGA). For different types of searches (e.g., SOTA search, device-specific search), the timeframes covered (e.g., SOTA search might be limited to the last five years, while safety database searches might have no date limit to capture all relevant events) and the rationale for these timeframes (e.g., rapid technological development or the need to comprehensively capture safety events) should be clearly stated.

To ensure transparency and auditability, any deviations from the original Literature Search Protocol (LSP) that occurred during actual execution, along with their justifications, must be explicitly recorded in this report. If there were no deviations, this should be clearly stated.

3. Confirmation of Search and Screening Criteria

Although the detailed list of search terms and inclusion/exclusion criteria would have been established in the LSP, the DCR often reaffirms or briefly restates the core inclusion and exclusion criteria that were strictly applied during the actual screening process. This helps the reader understand the basis for literature selection, for example, whether only peer-reviewed published studies were included, specific languages (e.g., English), and whether in-vitro studies, animal experiments, conference abstracts, review articles, etc., were excluded.

4. Brief Outline of Data Appraisal Methodology Applied

The DCR also needs to briefly review the data appraisal methods employed during the data screening and initial organization phase. This might include the criteria used to assess the relevance of literature to the device under evaluation and the research questions (e.g., using a scoring system to evaluate device match, application match, patient group match, report quality), as well as criteria for an initial judgment of the scientific quality of the literature. It should be stated how these appraisal criteria were consistently applied to all identified literature and any pre-set inclusion thresholds (e.g., only articles with a relevance score above a certain value were included for further analysis).

5. Presentation of Quantitative Results of the Literature Search

This is one of the core components of the DCR, presenting the specific execution results of the scientific literature search. This section should present, in a clear and structured manner:

• Search Details for Each Database: For each searched database, list the complete search strings actually used and the number of raw publications retrieved with that string.
• Summary of the Screening Process: Aggregate the total number of publications retrieved from all databases, the number remaining after removing duplicates, and the number of publications included and excluded after title/abstract screening and full-text review. It is highly recommended to use a PRISMA flowchart or a similar diagrammatic representation to intuitively display the complete screening pathway from initial search to final inclusion of literature, including the main reasons for excluding articles at each significant stage.

6. Results of Initial Appraisal of Included Literature and Data Extraction Summary

For literature that passed the screening and was initially deemed relevant, the DCR needs to display the results of its initial appraisal. Listing each included publication’s basic information (e.g., citation) along with its assigned scores or ratings from the relevance assessment and preliminary scientific quality appraisal, as well as the final decision on whether it was confirmed for in-depth analysis.

The DCR should outline the extraction of key data from these finally included publications. This section aims to show what information relevant to device safety, performance, study design, patient characteristics, etc., has been extracted from each important publication. A structured table is also typically used here, listing key data points extracted for each publication (e.g., number of patients/subjects, clinical safety outcomes, clinical performance outcomes, study design, device model used, study location, limitations, evidence level).

7. List of Excluded Articles

To ensure the completeness and transparency of the screening process, a DCR typically includes a list of articles that were excluded after full-text review, along with clear reasons for their exclusion.

8. Results from Safety Database Searches

Finally, the DCR must also specifically present the results retrieved from various safety databases. This part should clearly list the name of each safety database searched, the search date, the specific query parameters executed (e.g., device name, report date range), and the number of relevant items found. If specific adverse event reports, recall notices, etc., were retrieved, a preliminary categorization and summary of this information might also be required.

• 2000年1月4日中华人民共和国国务院令第276号公布; 2014年2月12日国务院第39次常务会议修订通过　
• 根据2017年5月4日《国务院关于修改〈医疗器械监督管理条例〉的决定》第一次修订; 2020年12月21日国务院第119次常务会议修订通过　
• 根据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第二次修订

第一章　总　　则

　　第一条　为了保证医疗器械的安全、有效，保障人体健康和生命安全，促进医疗器械产业发展，制定本条例。

       第二条　在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，适用本条例。

       第三条　国务院药品监督管理部门负责全国医疗器械监督管理工作。

       国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

       第四条　县级以上地方人民政府应当加强对本行政区域的医疗器械监督管理工作的领导，组织协调本行政区域内的医疗器械监督管理工作以及突发事件应对工作，加强医疗器械监督管理能力建设，为医疗器械安全工作提供保障。

       县级以上地方人民政府负责药品监督管理的部门负责本行政区域的医疗器械监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

       第五条　医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。

       第六条　国家对医疗器械按照风险程度实行分类管理。

       第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

       第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

       第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

       评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

       国务院药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类规则和分类目录进行调整。制定、调整分类规则和分类目录，应当充分听取医疗器械注册人、备案人、生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。医疗器械分类规则和分类目录应当向社会公布。

       第七条　医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。

       第八条　国家制定医疗器械产业规划和政策，将医疗器械创新纳入发展重点，对创新医疗器械予以优先审评审批，支持创新医疗器械临床推广和使用，推动医疗器械产业高质量发展。国务院药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和引导政策。

       第九条　国家完善医疗器械创新体系，支持医疗器械的基础研究和应用研究，促进医疗器械新技术的推广和应用，在科技立项、融资、信贷、招标采购、医疗保险等方面予以支持。支持企业设立或者联合组建研制机构，鼓励企业与高等学校、科研院所、医疗机构等合作开展医疗器械的研究与创新，加强医疗器械知识产权保护，提高医疗器械自主创新能力。

       第十条　国家加强医疗器械监督管理信息化建设，提高在线政务服务水平，为医疗器械行政许可、备案等提供便利。

       第十一条　医疗器械行业组织应当加强行业自律，推进诚信体系建设，督促企业依法开展生产经营活动，引导企业诚实守信。

       第十二条　对在医疗器械的研究与创新方面做出突出贡献的单位和个人，按照国家有关规定给予表彰奖励。

第二章　医疗器械产品注册与备案

　　第十三条　第一类医疗器械实行产品备案管理，第二类、第三类医疗器械实行产品注册管理。

       医疗器械注册人、备案人应当加强医疗器械全生命周期质量管理，对研制、生产、经营、使用全过程中医疗器械的安全性、有效性依法承担责任。

       第十四条　第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：

       (一)产品风险分析资料；

       (二)产品技术要求；

       (三)产品检验报告；

       (四)临床评价资料；

       (五)产品说明书以及标签样稿；

       (六)与产品研制、生产有关的质量管理体系文件；

       (七)证明产品安全、有效所需的其他资料。

       产品检验报告应当符合国务院药品监督管理部门的要求，可以是医疗器械注册申请人、备案人的自检报告，也可以是委托有资质的医疗器械检验机构出具的检验报告。

       符合本条例第二十四条规定的免于进行临床评价情形的，可以免于提交临床评价资料。

       医疗器械注册申请人、备案人应当确保提交的资料合法、真实、准确、完整和可追溯。

       第十五条　第一类医疗器械产品备案，由备案人向所在地设区的市级人民政府负责药品监督管理的部门提交备案资料。

       向我国境内出口第一类医疗器械的境外备案人，由其指定的我国境内企业法人向国务院药品监督管理部门提交备案资料和备案人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。未在境外上市的创新医疗器械，可以不提交备案人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。

       备案人向负责药品监督管理的部门提交符合本条例规定的备案资料后即完成备案。负责药品监督管理的部门应当自收到备案资料之日起5个工作日内，通过国务院药品监督管理部门在线政务服务平台向社会公布备案有关信息。

       备案资料载明的事项发生变化的，应当向原备案部门变更备案。

       第十六条　申请第二类医疗器械产品注册，注册申请人应当向所在地省、自治区、直辖市人民政府药品监督管理部门提交注册申请资料。申请第三类医疗器械产品注册，注册申请人应当向国务院药品监督管理部门提交注册申请资料。

       向我国境内出口第二类、第三类医疗器械的境外注册申请人，由其指定的我国境内企业法人向国务院药品监督管理部门提交注册申请资料和注册申请人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。未在境外上市的创新医疗器械，可以不提交注册申请人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。

       国务院药品监督管理部门应当对医疗器械注册审查程序和要求作出规定，并加强对省、自治区、直辖市人民政府药品监督管理部门注册审查工作的监督指导。

       第十七条　受理注册申请的药品监督管理部门应当对医疗器械的安全性、有效性以及注册申请人保证医疗器械安全、有效的质量管理能力等进行审查。

       受理注册申请的药品监督管理部门应当自受理注册申请之日起3个工作日内将注册申请资料转交技术审评机构。技术审评机构应当在完成技术审评后，将审评意见提交受理注册申请的药品监督管理部门作为审批的依据。

       受理注册申请的药品监督管理部门在组织对医疗器械的技术审评时认为有必要对质量管理体系进行核查的，应当组织开展质量管理体系核查。

       第十八条　受理注册申请的药品监督管理部门应当自收到审评意见之日起20个工作日内作出决定。对符合条件的，准予注册并发给医疗器械注册证；对不符合条件的，不予注册并书面说明理由。

       受理注册申请的药品监督管理部门应当自医疗器械准予注册之日起5个工作日内，通过国务院药品监督管理部门在线政务服务平台向社会公布注册有关信息。

       第十九条　对用于治疗罕见疾病、严重危及生命且尚无有效治疗手段的疾病和应对公共卫生事件等急需的医疗器械，受理注册申请的药品监督管理部门可以作出附条件批准决定，并在医疗器械注册证中载明相关事项。

       出现特别重大突发公共卫生事件或者其他严重威胁公众健康的紧急事件，国务院卫生主管部门、国务院疾病预防控制部门根据预防、控制事件的需要提出紧急使用医疗器械的建议，经国务院药品监督管理部门组织论证同意后可以在一定范围和期限内紧急使用。

       第二十条　医疗器械注册人、备案人应当履行下列义务：

       (一)建立与产品相适应的质量管理体系并保持有效运行；

       (二)制定上市后研究和风险管控计划并保证有效实施；

       (三)依法开展不良事件监测和再评价；

       (四)建立并执行产品追溯和召回制度；

       (五)国务院药品监督管理部门规定的其他义务。

       境外医疗器械注册人、备案人指定的我国境内企业法人应当协助注册人、备案人履行前款规定的义务。

       第二十一条　已注册的第二类、第三类医疗器械产品，其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化，有可能影响该医疗器械安全、有效的，注册人应当向原注册部门申请办理变更注册手续；发生其他变化的，应当按照国务院药品监督管理部门的规定备案或者报告。

       第二十二条　医疗器械注册证有效期为5年。有效期届满需要延续注册的，应当在有效期届满6个月前向原注册部门提出延续注册的申请。

       除有本条第三款规定情形外，接到延续注册申请的药品监督管理部门应当在医疗器械注册证有效期届满前作出准予延续的决定。逾期未作决定的，视为准予延续。

       有下列情形之一的，不予延续注册：

       (一)未在规定期限内提出延续注册申请；

       (二)医疗器械强制性标准已经修订，申请延续注册的医疗器械不能达到新要求；

       (三)附条件批准的医疗器械，未在规定期限内完成医疗器械注册证载明事项。

       第二十三条　对新研制的尚未列入分类目录的医疗器械，申请人可以依照本条例有关第三类医疗器械产品注册的规定直接申请产品注册，也可以依据分类规则判断产品类别并向国务院药品监督管理部门申请类别确认后依照本条例的规定申请产品注册或者进行产品备案。

       直接申请第三类医疗器械产品注册的，国务院药品监督管理部门应当按照风险程度确定类别，对准予注册的医疗器械及时纳入分类目录。申请类别确认的，国务院药品监督管理部门应当自受理申请之日起20个工作日内对该医疗器械的类别进行判定并告知申请人。

       第二十四条　医疗器械产品注册、备案，应当进行临床评价；但是符合下列情形之一，可以免于进行临床评价：

       (一)工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多年且无严重不良事件记录，不改变常规用途的；

       (二)其他通过非临床评价能够证明该医疗器械安全、有效的。

       国务院药品监督管理部门应当制定医疗器械临床评价指南。

       第二十五条　进行医疗器械临床评价，可以根据产品特征、临床风险、已有临床数据等情形，通过开展临床试验，或者通过对同品种医疗器械临床文献资料、临床数据进行分析评价，证明医疗器械安全、有效。

       按照国务院药品监督管理部门的规定，进行医疗器械临床评价时，已有临床文献资料、临床数据不足以确认产品安全、有效的医疗器械，应当开展临床试验。

       第二十六条　开展医疗器械临床试验，应当按照医疗器械临床试验质量管理规范的要求，在具备相应条件的临床试验机构进行，并向临床试验申办者所在地省、自治区、直辖市人民政府药品监督管理部门备案。接受临床试验备案的药品监督管理部门应当将备案情况通报临床试验机构所在地同级药品监督管理部门和卫生主管部门。

       医疗器械临床试验机构实行备案管理。医疗器械临床试验机构应当具备的条件以及备案管理办法和临床试验质量管理规范，由国务院药品监督管理部门会同国务院卫生主管部门制定并公布。

       国家支持医疗机构开展临床试验，将临床试验条件和能力评价纳入医疗机构等级评审，鼓励医疗机构开展创新医疗器械临床试验。

       第二十七条　第三类医疗器械临床试验对人体具有较高风险的，应当经国务院药品监督管理部门批准。国务院药品监督管理部门审批临床试验，应当对拟承担医疗器械临床试验的机构的设备、专业人员等条件，该医疗器械的风险程度，临床试验实施方案，临床受益与风险对比分析报告等进行综合分析，并自受理申请之日起60个工作日内作出决定并通知临床试验申办者。逾期未通知的，视为同意。准予开展临床试验的，应当通报临床试验机构所在地省、自治区、直辖市人民政府药品监督管理部门和卫生主管部门。

       临床试验对人体具有较高风险的第三类医疗器械目录由国务院药品监督管理部门制定、调整并公布。

       第二十八条　开展医疗器械临床试验，应当按照规定进行伦理审查，向受试者告知试验目的、用途和可能产生的风险等详细情况，获得受试者的书面知情同意；受试者为无民事行为能力人或者限制民事行为能力人的，应当依法获得其监护人的书面知情同意。

       开展临床试验，不得以任何形式向受试者收取与临床试验有关的费用。

       第二十九条　对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的医疗器械，经医学观察可能使患者获益，经伦理审查、知情同意后，可以在开展医疗器械临床试验的机构内免费用于其他病情相同的患者，其安全性数据可以用于医疗器械注册申请。

第三章　医疗器械生产

　　第三十条　从事医疗器械生产活动，应当具备下列条件：

       (一)有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员；

       (二)有能对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备；

       (三)有保证医疗器械质量的管理制度；

       (四)有与生产的医疗器械相适应的售后服务能力；

       (五)符合产品研制、生产工艺文件规定的要求。

       第三十一条　从事第一类医疗器械生产的，应当向所在地设区的市级人民政府负责药品监督管理的部门备案，在提交符合本条例第三十条规定条件的有关资料后即完成备案。

       医疗器械备案人自行生产第一类医疗器械的，可以在依照本条例第十五条规定进行产品备案时一并提交符合本条例第三十条规定条件的有关资料，即完成生产备案。

       第三十二条　从事第二类、第三类医疗器械生产的，应当向所在地省、自治区、直辖市人民政府药品监督管理部门申请生产许可并提交其符合本条例第三十条规定条件的有关资料以及所生产医疗器械的注册证。

       受理生产许可申请的药品监督管理部门应当对申请资料进行审核，按照国务院药品监督管理部门制定的医疗器械生产质量管理规范的要求进行核查，并自受理申请之日起20个工作日内作出决定。对符合规定条件的，准予许可并发给医疗器械生产许可证；对不符合规定条件的，不予许可并书面说明理由。

       医疗器械生产许可证有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

       第三十三条　医疗器械生产质量管理规范应当对医疗器械的设计开发、生产设备条件、原材料采购、生产过程控制、产品放行、企业的机构设置和人员配备等影响医疗器械安全、有效的事项作出明确规定。

       第三十四条　医疗器械注册人、备案人可以自行生产医疗器械，也可以委托符合本条例规定、具备相应条件的企业生产医疗器械。

       委托生产医疗器械的，医疗器械注册人、备案人应当对所委托生产的医疗器械质量负责，并加强对受托生产企业生产行为的管理，保证其按照法定要求进行生产。医疗器械注册人、备案人应当与受托生产企业签订委托协议，明确双方权利、义务和责任。受托生产企业应当依照法律法规、医疗器械生产质量管理规范、强制性标准、产品技术要求和委托协议组织生产，对生产行为负责，并接受委托方的监督。

       具有高风险的植入性医疗器械不得委托生产，具体目录由国务院药品监督管理部门制定、调整并公布。

       第三十五条　医疗器械注册人、备案人、受托生产企业应当按照医疗器械生产质量管理规范，建立健全与所生产医疗器械相适应的质量管理体系并保证其有效运行；严格按照经注册或者备案的产品技术要求组织生产，保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求。

       医疗器械注册人、备案人、受托生产企业应当定期对质量管理体系的运行情况进行自查，并按照国务院药品监督管理部门的规定提交自查报告。

       第三十六条　医疗器械的生产条件发生变化，不再符合医疗器械质量管理体系要求的，医疗器械注册人、备案人、受托生产企业应当立即采取整改措施；可能影响医疗器械安全、有效的，应当立即停止生产活动，并向原生产许可或者生产备案部门报告。

       第三十七条　医疗器械应当使用通用名称。通用名称应当符合国务院药品监督管理部门制定的医疗器械命名规则。

       第三十八条　国家根据医疗器械产品类别，分步实施医疗器械唯一标识制度，实现医疗器械可追溯，具体办法由国务院药品监督管理部门会同国务院有关部门制定。

       第三十九条　医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。

       医疗器械的说明书、标签应当标明下列事项：

       (一)通用名称、型号、规格；

       (二)医疗器械注册人、备案人、受托生产企业的名称、地址以及联系方式；

       (三)生产日期，使用期限或者失效日期；

       (四)产品性能、主要结构、适用范围；

       (五)禁忌、注意事项以及其他需要警示或者提示的内容；

       (六)安装和使用说明或者图示；

       (七)维护和保养方法，特殊运输、贮存的条件、方法；

       (八)产品技术要求规定应当标明的其他内容。

       第二类、第三类医疗器械还应当标明医疗器械注册证编号。

       由消费者个人自行使用的医疗器械还应当具有安全使用的特别说明。

第四章　医疗器械经营与使用

　　第四十条　从事医疗器械经营活动，应当有与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。

       第四十一条　从事第二类医疗器械经营的，由经营企业向所在地设区的市级人民政府负责药品监督管理的部门备案并提交符合本条例第四十条规定条件的有关资料。

       按照国务院药品监督管理部门的规定，对产品安全性、有效性不受流通过程影响的第二类医疗器械，可以免于经营备案。

       第四十二条　从事第三类医疗器械经营的，经营企业应当向所在地设区的市级人民政府负责药品监督管理的部门申请经营许可并提交符合本条例第四十条规定条件的有关资料。

       受理经营许可申请的负责药品监督管理的部门应当对申请资料进行审查，必要时组织核查，并自受理申请之日起20个工作日内作出决定。对符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规定条件的，不予许可并书面说明理由。

       医疗器械经营许可证有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

       第四十三条　医疗器械注册人、备案人经营其注册、备案的医疗器械，无需办理医疗器械经营许可或者备案，但应当符合本条例规定的经营条件。

       第四十四条　从事医疗器械经营，应当依照法律法规和国务院药品监督管理部门制定的医疗器械经营质量管理规范的要求，建立健全与所经营医疗器械相适应的质量管理体系并保证其有效运行。

       第四十五条　医疗器械经营企业、使用单位应当从具备合法资质的医疗器械注册人、备案人、生产经营企业购进医疗器械。购进医疗器械时，应当查验供货者的资质和医疗器械的合格证明文件，建立进货查验记录制度。从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业，还应当建立销售记录制度。

       记录事项包括：

       (一)医疗器械的名称、型号、规格、数量；

       (二)医疗器械的生产批号、使用期限或者失效日期、销售日期；

       (三)医疗器械注册人、备案人和受托生产企业的名称；

       (四)供货者或者购货者的名称、地址以及联系方式；

       (五)相关许可证明文件编号等。

       进货查验记录和销售记录应当真实、准确、完整和可追溯，并按照国务院药品监督管理部门规定的期限予以保存。国家鼓励采用先进技术手段进行记录。

       第四十六条　从事医疗器械网络销售的，应当是医疗器械注册人、备案人或者医疗器械经营企业。从事医疗器械网络销售的经营者，应当将从事医疗器械网络销售的相关信息告知所在地设区的市级人民政府负责药品监督管理的部门，经营第一类医疗器械和本条例第四十一条第二款规定的第二类医疗器械的除外。

       为医疗器械网络交易提供服务的电子商务平台经营者应当对入网医疗器械经营者进行实名登记，审查其经营许可、备案情况和所经营医疗器械产品注册、备案情况，并对其经营行为进行管理。电子商务平台经营者发现入网医疗器械经营者有违反本条例规定行为的，应当及时制止并立即报告医疗器械经营者所在地设区的市级人民政府负责药品监督管理的部门；发现严重违法行为的，应当立即停止提供网络交易平台服务。

       第四十七条　运输、贮存医疗器械，应当符合医疗器械说明书和标签标示的要求；对温度、湿度等环境条件有特殊要求的，应当采取相应措施，保证医疗器械的安全、有效。

       第四十八条　医疗器械使用单位应当有与在用医疗器械品种、数量相适应的贮存场所和条件。医疗器械使用单位应当加强对工作人员的技术培训，按照产品说明书、技术操作规范等要求使用医疗器械。

       医疗器械使用单位配置大型医用设备，应当符合国务院卫生主管部门制定的大型医用设备配置规划，与其功能定位、临床服务需求相适应，具有相应的技术条件、配套设施和具备相应资质、能力的专业技术人员，并经省级以上人民政府卫生主管部门批准，取得大型医用设备配置许可证。

       大型医用设备配置管理办法由国务院卫生主管部门会同国务院有关部门制定。大型医用设备目录由国务院卫生主管部门商国务院有关部门提出，报国务院批准后执行。

       第四十九条　医疗器械使用单位对重复使用的医疗器械，应当按照国务院卫生主管部门制定的消毒和管理的规定进行处理。

       一次性使用的医疗器械不得重复使用，对使用过的应当按照国家有关规定销毁并记录。一次性使用的医疗器械目录由国务院药品监督管理部门会同国务院卫生主管部门制定、调整并公布。列入一次性使用的医疗器械目录，应当具有充足的无法重复使用的证据理由。重复使用可以保证安全、有效的医疗器械，不列入一次性使用的医疗器械目录。对因设计、生产工艺、消毒灭菌技术等改进后重复使用可以保证安全、有效的医疗器械，应当调整出一次性使用的医疗器械目录，允许重复使用。

       第五十条　医疗器械使用单位对需要定期检查、检验、校准、保养、维护的医疗器械，应当按照产品说明书的要求进行检查、检验、校准、保养、维护并予以记录，及时进行分析、评估，确保医疗器械处于良好状态，保障使用质量；对使用期限长的大型医疗器械，应当逐台建立使用档案，记录其使用、维护、转让、实际使用时间等事项。记录保存期限不得少于医疗器械规定使用期限终止后5年。

       第五十一条　医疗器械使用单位应当妥善保存购入第三类医疗器械的原始资料，并确保信息具有可追溯性。

       使用大型医疗器械以及植入和介入类医疗器械的，应当将医疗器械的名称、关键性技术参数等信息以及与使用质量安全密切相关的必要信息记载到病历等相关记录中。

       第五十二条　发现使用的医疗器械存在安全隐患的，医疗器械使用单位应当立即停止使用，并通知医疗器械注册人、备案人或者其他负责产品质量的机构进行检修；经检修仍不能达到使用安全标准的医疗器械，不得继续使用。

       第五十三条　对国内尚无同品种产品上市的体外诊断试剂，符合条件的医疗机构根据本单位的临床需要，可以自行研制，在执业医师指导下在本单位内使用。具体管理办法由国务院药品监督管理部门会同国务院卫生主管部门制定。

       第五十四条　负责药品监督管理的部门和卫生主管部门依据各自职责，分别对使用环节的医疗器械质量和医疗器械使用行为进行监督管理。

       第五十五条　医疗器械经营企业、使用单位不得经营、使用未依法注册或者备案、无合格证明文件以及过期、失效、淘汰的医疗器械。

       第五十六条　医疗器械使用单位之间转让在用医疗器械，转让方应当确保所转让的医疗器械安全、有效，不得转让过期、失效、淘汰以及检验不合格的医疗器械。

       第五十七条　进口的医疗器械应当是依照本条例第二章的规定已注册或者已备案的医疗器械。

       进口的医疗器械应当有中文说明书、中文标签。说明书、标签应当符合本条例规定以及相关强制性标准的要求，并在说明书中载明医疗器械的原产地以及境外医疗器械注册人、备案人指定的我国境内企业法人的名称、地址、联系方式。没有中文说明书、中文标签或者说明书、标签不符合本条规定的，不得进口。

       医疗机构因临床急需进口少量第二类、第三类医疗器械的，经国务院药品监督管理部门或者国务院授权的省、自治区、直辖市人民政府批准，可以进口。进口的医疗器械应当在指定医疗机构内用于特定医疗目的。

       禁止进口过期、失效、淘汰等已使用过的医疗器械。

       第五十八条　出入境检验检疫机构依法对进口的医疗器械实施检验；检验不合格的，不得进口。

       国务院药品监督管理部门应当及时向国家出入境检验检疫部门通报进口医疗器械的注册和备案情况。进口口岸所在地出入境检验检疫机构应当及时向所在地设区的市级人民政府负责药品监督管理的部门通报进口医疗器械的通关情况。

       第五十九条　出口医疗器械的企业应当保证其出口的医疗器械符合进口国(地区)的要求。

       第六十条　医疗器械广告的内容应当真实合法，以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准，不得含有虚假、夸大、误导性的内容。

       发布医疗器械广告，应当在发布前由省、自治区、直辖市人民政府确定的广告审查机关对广告内容进行审查，并取得医疗器械广告批准文号；未经审查，不得发布。

       省级以上人民政府药品监督管理部门责令暂停生产、进口、经营和使用的医疗器械，在暂停期间不得发布涉及该医疗器械的广告。

       医疗器械广告的审查办法由国务院市场监督管理部门制定。

第五章　不良事件的处理与医疗器械的召回

　　第六十一条　国家建立医疗器械不良事件监测制度，对医疗器械不良事件及时进行收集、分析、评价、控制。

       第六十二条　医疗器械注册人、备案人应当建立医疗器械不良事件监测体系，配备与其产品相适应的不良事件监测机构和人员，对其产品主动开展不良事件监测，并按照国务院药品监督管理部门的规定，向医疗器械不良事件监测技术机构报告调查、分析、评价、产品风险控制等情况。

       医疗器械生产经营企业、使用单位应当协助医疗器械注册人、备案人对所生产经营或者使用的医疗器械开展不良事件监测；发现医疗器械不良事件或者可疑不良事件，应当按照国务院药品监督管理部门的规定，向医疗器械不良事件监测技术机构报告。

       其他单位和个人发现医疗器械不良事件或者可疑不良事件，有权向负责药品监督管理的部门或者医疗器械不良事件监测技术机构报告。

       第六十三条　国务院药品监督管理部门应当加强医疗器械不良事件监测信息网络建设。

       医疗器械不良事件监测技术机构应当加强医疗器械不良事件信息监测，主动收集不良事件信息；发现不良事件或者接到不良事件报告的，应当及时进行核实，必要时进行调查、分析、评估，向负责药品监督管理的部门和卫生主管部门报告并提出处理建议。

       医疗器械不良事件监测技术机构应当公布联系方式，方便医疗器械注册人、备案人、生产经营企业、使用单位等报告医疗器械不良事件。

       第六十四条　负责药品监督管理的部门应当根据医疗器械不良事件评估结果及时采取发布警示信息以及责令暂停生产、进口、经营和使用等控制措施。

       省级以上人民政府药品监督管理部门应当会同同级卫生主管部门和相关部门组织对引起突发、群发的严重伤害或者死亡的医疗器械不良事件及时进行调查和处理，并组织对同类医疗器械加强监测。

       负责药品监督管理的部门应当及时向同级卫生主管部门通报医疗器械使用单位的不良事件监测有关情况。

       第六十五条　医疗器械注册人、备案人、生产经营企业、使用单位应当对医疗器械不良事件监测技术机构、负责药品监督管理的部门、卫生主管部门开展的医疗器械不良事件调查予以配合。

       第六十六条　有下列情形之一的，医疗器械注册人、备案人应当主动开展已上市医疗器械再评价：

       (一)根据科学研究的发展，对医疗器械的安全、有效有认识上的改变；

       (二)医疗器械不良事件监测、评估结果表明医疗器械可能存在缺陷；

       (三)国务院药品监督管理部门规定的其他情形。

       医疗器械注册人、备案人应当根据再评价结果，采取相应控制措施，对已上市医疗器械进行改进，并按照规定进行注册变更或者备案变更。再评价结果表明已上市医疗器械不能保证安全、有效的，医疗器械注册人、备案人应当主动申请注销医疗器械注册证或者取消备案；医疗器械注册人、备案人未申请注销医疗器械注册证或者取消备案的，由负责药品监督管理的部门注销医疗器械注册证或者取消备案。

       省级以上人民政府药品监督管理部门根据医疗器械不良事件监测、评估等情况，对已上市医疗器械开展再评价。再评价结果表明已上市医疗器械不能保证安全、有效的，应当注销医疗器械注册证或者取消备案。

       负责药品监督管理的部门应当向社会及时公布注销医疗器械注册证和取消备案情况。被注销医疗器械注册证或者取消备案的医疗器械不得继续生产、进口、经营、使用。

       第六十七条　医疗器械注册人、备案人发现生产的医疗器械不符合强制性标准、经注册或者备案的产品技术要求，或者存在其他缺陷的，应当立即停止生产，通知相关经营企业、使用单位和消费者停止经营和使用，召回已经上市销售的医疗器械，采取补救、销毁等措施，记录相关情况，发布相关信息，并将医疗器械召回和处理情况向负责药品监督管理的部门和卫生主管部门报告。

       医疗器械受托生产企业、经营企业发现生产、经营的医疗器械存在前款规定情形的，应当立即停止生产、经营，通知医疗器械注册人、备案人，并记录停止生产、经营和通知情况。医疗器械注册人、备案人认为属于依照前款规定需要召回的医疗器械，应当立即召回。

       医疗器械注册人、备案人、受托生产企业、经营企业未依照本条规定实施召回或者停止生产、经营的，负责药品监督管理的部门可以责令其召回或者停止生产、经营。

第六章　监督检查

　　第六十八条　国家建立职业化专业化检查员制度，加强对医疗器械的监督检查。

       第六十九条　负责药品监督管理的部门应当对医疗器械的研制、生产、经营活动以及使用环节的医疗器械质量加强监督检查，并对下列事项进行重点监督检查：

       (一)是否按照经注册或者备案的产品技术要求组织生产；

       (二)质量管理体系是否保持有效运行；

       (三)生产经营条件是否持续符合法定要求。

       必要时，负责药品监督管理的部门可以对为医疗器械研制、生产、经营、使用等活动提供产品或者服务的其他相关单位和个人进行延伸检查。

       第七十条　负责药品监督管理的部门在监督检查中有下列职权：

       (一)进入现场实施检查、抽取样品；

       (二)查阅、复制、查封、扣押有关合同、票据、账簿以及其他有关资料；

       (三)查封、扣押不符合法定要求的医疗器械，违法使用的零配件、原材料以及用于违法生产经营医疗器械的工具、设备；

       (四)查封违反本条例规定从事医疗器械生产经营活动的场所。

       进行监督检查，应当出示执法证件，保守被检查单位的商业秘密。

       有关单位和个人应当对监督检查予以配合，提供相关文件和资料，不得隐瞒、拒绝、阻挠。

       第七十一条　卫生主管部门应当对医疗机构的医疗器械使用行为加强监督检查。实施监督检查时，可以进入医疗机构，查阅、复制有关档案、记录以及其他有关资料。

       第七十二条　医疗器械生产经营过程中存在产品质量安全隐患，未及时采取措施消除的，负责药品监督管理的部门可以采取告诫、责任约谈、责令限期整改等措施。

       对人体造成伤害或者有证据证明可能危害人体健康的医疗器械，负责药品监督管理的部门可以采取责令暂停生产、进口、经营、使用的紧急控制措施，并发布安全警示信息。

       第七十三条　负责药品监督管理的部门应当加强对医疗器械注册人、备案人、生产经营企业和使用单位生产、经营、使用的医疗器械的抽查检验。抽查检验不得收取检验费和其他任何费用，所需费用纳入本级政府预算。省级以上人民政府药品监督管理部门应当根据抽查检验结论及时发布医疗器械质量公告。

       卫生主管部门应当对大型医用设备的使用状况进行监督和评估；发现违规使用以及与大型医用设备相关的过度检查、过度治疗等情形的，应当立即纠正，依法予以处理。

       第七十四条　负责药品监督管理的部门未及时发现医疗器械安全系统性风险，未及时消除监督管理区域内医疗器械安全隐患的，本级人民政府或者上级人民政府负责药品监督管理的部门应当对其主要负责人进行约谈。

       地方人民政府未履行医疗器械安全职责，未及时消除区域性重大医疗器械安全隐患的，上级人民政府或者上级人民政府负责药品监督管理的部门应当对其主要负责人进行约谈。

       被约谈的部门和地方人民政府应当立即采取措施，对医疗器械监督管理工作进行整改。

       第七十五条　医疗器械检验机构资质认定工作按照国家有关规定实行统一管理。经国务院认证认可监督管理部门会同国务院药品监督管理部门认定的检验机构，方可对医疗器械实施检验。

       负责药品监督管理的部门在执法工作中需要对医疗器械进行检验的，应当委托有资质的医疗器械检验机构进行，并支付相关费用。

       当事人对检验结论有异议的，可以自收到检验结论之日起7个工作日内向实施抽样检验的部门或者其上一级负责药品监督管理的部门提出复检申请，由受理复检申请的部门在复检机构名录中随机确定复检机构进行复检。承担复检工作的医疗器械检验机构应当在国务院药品监督管理部门规定的时间内作出复检结论。复检结论为最终检验结论。复检机构与初检机构不得为同一机构；相关检验项目只有一家有资质的检验机构的，复检时应当变更承办部门或者人员。复检机构名录由国务院药品监督管理部门公布。

       第七十六条　对可能存在有害物质或者擅自改变医疗器械设计、原材料和生产工艺并存在安全隐患的医疗器械，按照医疗器械国家标准、行业标准规定的检验项目和检验方法无法检验的，医疗器械检验机构可以使用国务院药品监督管理部门批准的补充检验项目和检验方法进行检验；使用补充检验项目、检验方法得出的检验结论，可以作为负责药品监督管理的部门认定医疗器械质量的依据。

       第七十七条　市场监督管理部门应当依照有关广告管理的法律、行政法规的规定，对医疗器械广告进行监督检查，查处违法行为。

       第七十八条　负责药品监督管理的部门应当通过国务院药品监督管理部门在线政务服务平台依法及时公布医疗器械许可、备案、抽查检验、违法行为查处等日常监督管理信息。但是，不得泄露当事人的商业秘密。

       负责药品监督管理的部门建立医疗器械注册人、备案人、生产经营企业、使用单位信用档案，对有不良信用记录的增加监督检查频次，依法加强失信惩戒。

       第七十九条　负责药品监督管理的部门等部门应当公布本单位的联系方式，接受咨询、投诉、举报。负责药品监督管理的部门等部门接到与医疗器械监督管理有关的咨询，应当及时答复；接到投诉、举报，应当及时核实、处理、答复。对咨询、投诉、举报情况及其答复、核实、处理情况，应当予以记录、保存。

       有关医疗器械研制、生产、经营、使用行为的举报经调查属实的，负责药品监督管理的部门等部门对举报人应当给予奖励。有关部门应当为举报人保密。

       第八十条　国务院药品监督管理部门制定、调整、修改本条例规定的目录以及与医疗器械监督管理有关的规范，应当公开征求意见；采取听证会、论证会等形式，听取专家、医疗器械注册人、备案人、生产经营企业、使用单位、消费者、行业协会以及相关组织等方面的意见。

第七章　法律责任

　　第八十一条　有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的医疗器械和用于违法生产经营的工具、设备、原材料等物品；违法生产经营的医疗器械货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业，10年内不受理相关责任人以及单位提出的医疗器械许可申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，终身禁止其从事医疗器械生产经营活动：

       (一)生产、经营未取得医疗器械注册证的第二类、第三类医疗器械；

       (二)未经许可从事第二类、第三类医疗器械生产活动；

       (三)未经许可从事第三类医疗器械经营活动。

       有前款第一项情形、情节严重的，由原发证部门吊销医疗器械生产许可证或者医疗器械经营许可证。

       第八十二条　未经许可擅自配置使用大型医用设备的，由县级以上人民政府卫生主管部门责令停止使用，给予警告，没收违法所得；违法所得不足1万元的，并处5万元以上10万元以下罚款；违法所得1万元以上的，并处违法所得10倍以上30倍以下罚款；情节严重的，5年内不受理相关责任人以及单位提出的大型医用设备配置许可申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

       第八十三条　在申请医疗器械行政许可时提供虚假资料或者采取其他欺骗手段的，不予行政许可，已经取得行政许可的，由作出行政许可决定的部门撤销行政许可，没收违法所得、违法生产经营使用的医疗器械，10年内不受理相关责任人以及单位提出的医疗器械许可申请；违法生产经营使用的医疗器械货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，终身禁止其从事医疗器械生产经营活动。

       伪造、变造、买卖、出租、出借相关医疗器械许可证件的，由原发证部门予以收缴或者吊销，没收违法所得；违法所得不足1万元的，并处5万元以上10万元以下罚款；违法所得1万元以上的，并处违法所得10倍以上20倍以下罚款；构成违反治安管理行为的，由公安机关依法予以治安管理处罚。

       第八十四条　有下列情形之一的，由负责药品监督管理的部门向社会公告单位和产品名称，责令限期改正；逾期不改正的，没收违法所得、违法生产经营的医疗器械；违法生产经营的医疗器械货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：

       (一)生产、经营未经备案的第一类医疗器械；

       (二)未经备案从事第一类医疗器械生产；

       (三)经营第二类医疗器械，应当备案但未备案；

       (四)已经备案的资料不符合要求。

       第八十五条　备案时提供虚假资料的，由负责药品监督管理的部门向社会公告备案单位和产品名称，没收违法所得、违法生产经营的医疗器械；违法生产经营的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动。

       第八十六条　有下列情形之一的，由负责药品监督管理的部门责令改正，没收违法生产经营使用的医疗器械；违法生产经营使用的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动：

       (一)生产、经营、使用不符合强制性标准或者不符合经注册或者备案的产品技术要求的医疗器械；

       (二)未按照经注册或者备案的产品技术要求组织生产，或者未依照本条例规定建立质量管理体系并保持有效运行，影响产品安全、有效；

       (三)经营、使用无合格证明文件、过期、失效、淘汰的医疗器械，或者使用未依法注册的医疗器械；

       (四)在负责药品监督管理的部门责令召回后仍拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、进口、经营后，仍拒不停止生产、进口、经营医疗器械；

       (五)委托不具备本条例规定条件的企业生产医疗器械，或者未对受托生产企业的生产行为进行管理；

       (六)进口过期、失效、淘汰等已使用过的医疗器械。

       第八十七条　医疗器械经营企业、使用单位履行了本条例规定的进货查验等义务，有充分证据证明其不知道所经营、使用的医疗器械为本条例第八十一条第一款第一项、第八十四条第一项、第八十六条第一项和第三项规定情形的医疗器械，并能如实说明其进货来源的，收缴其经营、使用的不符合法定要求的医疗器械，可以免除行政处罚。

       第八十八条　有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：

       (一)生产条件发生变化、不再符合医疗器械质量管理体系要求，未依照本条例规定整改、停止生产、报告；

       (二)生产、经营说明书、标签不符合本条例规定的医疗器械；

       (三)未按照医疗器械说明书和标签标示要求运输、贮存医疗器械；

       (四)转让过期、失效、淘汰或者检验不合格的在用医疗器械。

       第八十九条　有下列情形之一的，由负责药品监督管理的部门和卫生主管部门依据各自职责责令改正，给予警告；拒不改正的，处1万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员处1万元以上3万元以下罚款：

       (一)未按照要求提交质量管理体系自查报告；

       (二)从不具备合法资质的供货者购进医疗器械；

       (三)医疗器械经营企业、使用单位未依照本条例规定建立并执行医疗器械进货查验记录制度；

       (四)从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业未依照本条例规定建立并执行销售记录制度；

       (五)医疗器械注册人、备案人、生产经营企业、使用单位未依照本条例规定开展医疗器械不良事件监测，未按照要求报告不良事件，或者对医疗器械不良事件监测技术机构、负责药品监督管理的部门、卫生主管部门开展的不良事件调查不予配合；

       (六)医疗器械注册人、备案人未按照规定制定上市后研究和风险管控计划并保证有效实施；

       (七)医疗器械注册人、备案人未按照规定建立并执行产品追溯制度；

       (八)医疗器械注册人、备案人、经营企业从事医疗器械网络销售未按照规定告知负责药品监督管理的部门；

       (九)对需要定期检查、检验、校准、保养、维护的医疗器械，医疗器械使用单位未按照产品说明书要求进行检查、检验、校准、保养、维护并予以记录，及时进行分析、评估，确保医疗器械处于良好状态；

       (十)医疗器械使用单位未妥善保存购入第三类医疗器械的原始资料。

       第九十条　有下列情形之一的，由县级以上人民政府卫生主管部门责令改正，给予警告；拒不改正的，处5万元以上10万元以下罚款；情节严重的，处10万元以上30万元以下罚款，责令暂停相关医疗器械使用活动，直至由原发证部门吊销执业许可证，依法责令相关责任人员暂停6个月以上1年以下执业活动，直至由原发证部门吊销相关人员执业证书，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分：

       (一)对重复使用的医疗器械，医疗器械使用单位未按照消毒和管理的规定进行处理；

       (二)医疗器械使用单位重复使用一次性使用的医疗器械，或者未按照规定销毁使用过的一次性使用的医疗器械；

       (三)医疗器械使用单位未按照规定将大型医疗器械以及植入和介入类医疗器械的信息记载到病历等相关记录中；

       (四)医疗器械使用单位发现使用的医疗器械存在安全隐患未立即停止使用、通知检修，或者继续使用经检修仍不能达到使用安全标准的医疗器械；

       (五)医疗器械使用单位违规使用大型医用设备，不能保障医疗质量安全。

       第九十一条　违反进出口商品检验相关法律、行政法规进口医疗器械的，由出入境检验检疫机构依法处理。

       第九十二条　为医疗器械网络交易提供服务的电子商务平台经营者违反本条例规定，未履行对入网医疗器械经营者进行实名登记，审查许可、注册、备案情况，制止并报告违法行为，停止提供网络交易平台服务等管理义务的，由负责药品监督管理的部门依照《中华人民共和国电子商务法》的规定给予处罚。

       第九十三条　未进行医疗器械临床试验机构备案开展临床试验的，由负责药品监督管理的部门责令停止临床试验并改正；拒不改正的，该临床试验数据不得用于产品注册、备案，处5万元以上10万元以下罚款，并向社会公告；造成严重后果的，5年内禁止其开展相关专业医疗器械临床试验，并处10万元以上30万元以下罚款，由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

       临床试验申办者开展临床试验未经备案的，由负责药品监督管理的部门责令停止临床试验，对临床试验申办者处5万元以上10万元以下罚款，并向社会公告；造成严重后果的，处10万元以上30万元以下罚款。该临床试验数据不得用于产品注册、备案，5年内不受理相关责任人以及单位提出的医疗器械注册申请。

       临床试验申办者未经批准开展对人体具有较高风险的第三类医疗器械临床试验的，由负责药品监督管理的部门责令立即停止临床试验，对临床试验申办者处10万元以上30万元以下罚款，并向社会公告；造成严重后果的，处30万元以上100万元以下罚款。该临床试验数据不得用于产品注册，10年内不受理相关责任人以及单位提出的医疗器械临床试验和注册申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款。

       第九十四条　医疗器械临床试验机构开展医疗器械临床试验未遵守临床试验质量管理规范的，由负责药品监督管理的部门责令改正或者立即停止临床试验，处5万元以上10万元以下罚款；造成严重后果的，5年内禁止其开展相关专业医疗器械临床试验，由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

       第九十五条　医疗器械临床试验机构出具虚假报告的，由负责药品监督管理的部门处10万元以上30万元以下罚款；有违法所得的，没收违法所得；10年内禁止其开展相关专业医疗器械临床试验；由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

       第九十六条　医疗器械检验机构出具虚假检验报告的，由授予其资质的主管部门撤销检验资质，10年内不受理相关责任人以及单位提出的资质认定申请，并处10万元以上30万元以下罚款；有违法所得的，没收违法所得；对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分；受到开除处分的，10年内禁止其从事医疗器械检验工作。

       第九十七条　违反本条例有关医疗器械广告管理规定的，依照《中华人民共和国广告法》的规定给予处罚。

       第九十八条　境外医疗器械注册人、备案人指定的我国境内企业法人未依照本条例规定履行相关义务的，由省、自治区、直辖市人民政府药品监督管理部门责令改正，给予警告，并处5万元以上10万元以下罚款；情节严重的，处10万元以上50万元以下罚款，5年内禁止其法定代表人、主要负责人、直接负责的主管人员和其他责任人员从事医疗器械生产经营活动。

       境外医疗器械注册人、备案人拒不履行依据本条例作出的行政处罚决定的，10年内禁止其医疗器械进口。

       第九十九条　医疗器械研制、生产、经营单位和检验机构违反本条例规定使用禁止从事医疗器械生产经营活动、检验工作的人员的，由负责药品监督管理的部门责令改正，给予警告；拒不改正的，责令停产停业直至吊销许可证件。

       第一百条　医疗器械技术审评机构、医疗器械不良事件监测技术机构未依照本条例规定履行职责，致使审评、监测工作出现重大失误的，由负责药品监督管理的部门责令改正，通报批评，给予警告；造成严重后果的，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，依法给予处分。

       第一百零一条　负责药品监督管理的部门或者其他有关部门工作人员违反本条例规定，滥用职权、玩忽职守、徇私舞弊的，依法给予处分。

       第一百零二条　违反本条例规定，构成犯罪的，依法追究刑事责任；造成人身、财产或者其他损害的，依法承担赔偿责任。

第八章　附　　则

　　第一百零三条　本条例下列用语的含义：

       医疗器械，是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件；其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；其目的是：

       (一)疾病的诊断、预防、监护、治疗或者缓解；

       (二)损伤的诊断、监护、治疗、缓解或者功能补偿；

       (三)生理结构或者生理过程的检验、替代、调节或者支持；

       (四)生命的支持或者维持；

       (五)妊娠控制；

       (六)通过对来自人体的样本进行检查，为医疗或者诊断目的提供信息。

       医疗器械注册人、备案人，是指取得医疗器械注册证或者办理医疗器械备案的企业或者研制机构。

       医疗器械使用单位，是指使用医疗器械为他人提供医疗等技术服务的机构，包括医疗机构、血站、单采血浆站、康复辅助器具适配机构等。

       大型医用设备，是指使用技术复杂、资金投入量大、运行成本高、对医疗费用影响大且纳入目录管理的大型医疗器械。

       第一百零四条　医疗器械产品注册可以收取费用。具体收费项目、标准分别由国务院财政、价格主管部门按照国家有关规定制定。

       第一百零五条　医疗卫生机构为应对突发公共卫生事件而研制的医疗器械的管理办法，由国务院药品监督管理部门会同国务院卫生主管部门制定。

       从事非营利的避孕医疗器械的存储、调拨和供应，应当遵守国务院卫生主管部门会同国务院药品监督管理部门制定的管理办法。

       中医医疗器械的技术指导原则，由国务院药品监督管理部门会同国务院中医药管理部门制定。

       第一百零六条　军队医疗器械使用的监督管理，依照本条例和军队有关规定执行。

       第一百零七条　本条例自2021年6月1日起施行。

　　第一条　为规范医疗器械分类，根据《医疗器械监督管理条例》，制定本规则。

　　第二条　本规则用于指导制定医疗器械分类目录和确定新的医疗器械的管理类别。

　　第三条　本规则有关用语的含义是：

　　（一）预期目的
　　指产品说明书、标签或者宣传资料载明的，使用医疗器械应当取得的作用。

　　（二）无源医疗器械
　　不依靠电能或者其他能源，但是可以通过由人体或者重力产生的能量，发挥其功能的医疗器械。

　　（三）有源医疗器械
　　任何依靠电能或者其他能源，而不是直接由人体或者重力产生的能量，发挥其功能的医疗器械。

　　（四）侵入器械
　　借助手术全部或者部分通过体表侵入人体，接触体内组织、血液循环系统、中枢神经系统等部位的医疗器械，包括介入手术中使用的器材、一次性使用无菌手术器械和暂时或短期留在人体内的器械等。本规则中的侵入器械不包括重复使用手术器械。

　　（五）重复使用手术器械
　　用于手术中进行切、割、钻、锯、抓、刮、钳、抽、夹等过程，不连接任何有源医疗器械，通过一定的处理可以重新使用的无源医疗器械。

　　（六）植入器械
　　借助手术全部或者部分进入人体内或腔道（口）中，或者用于替代人体上皮表面或眼表面，并且在手术过程结束后留在人体内30日（含）以上或者被人体吸收的医疗器械。

　　（七）接触人体器械
　　直接或间接接触患者或者能够进入患者体内的医疗器械。

　　（八）使用时限
　　1.连续使用时间：医疗器械按预期目的、不间断的实际作用时间；
　　2.暂时：医疗器械预期的连续使用时间在24小时以内；
　　3.短期：医疗器械预期的连续使用时间在24小时（含）以上、30日以内；
　　4.长期：医疗器械预期的连续使用时间在30日（含）以上。

　　（九）皮肤
　　未受损皮肤表面。

　　（十）腔道（口）
　　口腔、鼻腔、食道、外耳道、直肠、阴道、尿道等人体自然腔道和永久性人造开口。

　　（十一）创伤
　　各种致伤因素作用于人体所造成的组织结构完整性破坏或者功能障碍。

　　（十二）组织
　　人体体内组织，包括骨、牙髓或者牙本质，不包括血液循环系统和中枢神经系统。

　　（十三）血液循环系统
　　血管（毛细血管除外）和心脏。

　　（十四）中枢神经系统
　　脑和脊髓。

　　（十五）独立软件
　　具有一个或者多个医疗目的，无需医疗器械硬件即可完成自身预期目的，运行于通用计算平台的软件。

　　（十六）具有计量测试功能的医疗器械
　　用于测定生理、病理、解剖参数，或者定量测定进出人体的能量或物质的医疗器械，其测量结果需要精确定量，并且该结果的准确性会对患者的健康和安全产生明显影响。

　　（十七）慢性创面
　　各种原因形成的长期不愈合创面，如静脉性溃疡、动脉性溃疡、糖尿病性溃疡、创伤性溃疡、压力性溃疡等。

　　第四条　医疗器械按照风险程度由低到高，管理类别依次分为第一类、第二类和第三类。
　　医疗器械风险程度，应当根据医疗器械的预期目的，通过结构特征、使用形式、使用状态、是否接触人体等因素综合判定。

　　第五条　依据影响医疗器械风险程度的因素，医疗器械可以分为以下几种情形：
　　（一）根据结构特征的不同，分为无源医疗器械和有源医疗器械。

　　（二）根据是否接触人体，分为接触人体器械和非接触人体器械。

　　（三）根据不同的结构特征和是否接触人体，医疗器械的使用形式包括：
　　无源接触人体器械：液体输送器械、改变血液体液器械、医用敷料、侵入器械、重复使用手术器械、植入器械、避孕和计划生育器械、其他无源接触人体器械。

　　无源非接触人体器械：护理器械、医疗器械清洗消毒器械、其他无源非接触人体器械。

　　有源接触人体器械：能量治疗器械、诊断监护器械、液体输送器械、电离辐射器械、植入器械、其他有源接触人体器械。

　　有源非接触人体器械：临床检验仪器设备、独立软件、医疗器械消毒灭菌设备、其他有源非接触人体器械。

　　（四）根据不同的结构特征、是否接触人体以及使用形式，医疗器械的使用状态或者其产生的影响包括以下情形：
　　无源接触人体器械：根据使用时限分为暂时使用、短期使用、长期使用；接触人体的部位分为皮肤或腔道（口）、创伤或组织、血液循环系统或中枢神经系统。

　　无源非接触人体器械：根据对医疗效果的影响程度分为基本不影响、轻微影响、重要影响。

　　有源接触人体器械：根据失控后可能造成的损伤程度分为轻微损伤、中度损伤、严重损伤。

　　有源非接触人体器械：根据对医疗效果的影响程度分为基本不影响、轻微影响、重要影响。

　　第六条　医疗器械的分类应当根据医疗器械分类判定表（见附件）进行分类判定。有以下情形的，还应当结合下述原则进行分类：

　　（一）如果同一医疗器械适用两个或者两个以上的分类，应当采取其中风险程度最高的分类；由多个医疗器械组成的医疗器械包，其分类应当与包内风险程度最高的医疗器械一致。

　　（二）可作为附件的医疗器械，其分类应当综合考虑该附件对配套主体医疗器械安全性、有效性的影响；如果附件对配套主体医疗器械有重要影响，附件的分类应不低于配套主体医疗器械的分类。

　　（三）监控或者影响医疗器械主要功能的医疗器械，其分类应当与被监控、影响的医疗器械的分类一致。

　　（四）以医疗器械作用为主的药械组合产品，按照第三类医疗器械管理。

　　（五）可被人体吸收的医疗器械，按照第三类医疗器械管理。

　　（六）对医疗效果有重要影响的有源接触人体器械，按照第三类医疗器械管理。

　　（七）医用敷料如果有以下情形，按照第三类医疗器械管理，包括：预期具有防组织或器官粘连功能，作为人工皮肤，接触真皮深层或其以下组织受损的创面，用于慢性创面，或者可被人体全部或部分吸收的。

　　（八）以无菌形式提供的医疗器械，其分类应不低于第二类。

　　（九）通过牵拉、撑开、扭转、压握、弯曲等作用方式，主动施加持续作用力于人体、可动态调整肢体固定位置的矫形器械（不包括仅具有固定、支撑作用的医疗器械，也不包括配合外科手术中进行临时矫形的医疗器械或者外科手术后或其他治疗中进行四肢矫形的医疗器械），其分类应不低于第二类。

　　（十）具有计量测试功能的医疗器械，其分类应不低于第二类。

　　（十一）如果医疗器械的预期目的是明确用于某种疾病的治疗，其分类应不低于第二类。

　　（十二）用于在内窥镜下完成夹取、切割组织或者取石等手术操作的无源重复使用手术器械，按照第二类医疗器械管理。

　　第七条　体外诊断试剂按照有关规定进行分类。

　　第八条　国家食品药品监督管理总局根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对医疗器械分类目录进行调整。

　　第九条　国家食品药品监督管理总局可以组织医疗器械分类专家委员会制定、调整医疗器械分类目录。

　　第十条　本规则自2016年1月1日起施行。2000年4月5日公布的《医疗器械分类规则》（原国家药品监督管理局令第15号）同时废止。

　　附件：医疗器械分类判定表

第一条　为规范医疗器械说明书和标签，保证医疗器械使用的安全，根据《医疗器械监督管理条例》，制定本规定。

　　第二条　凡在中华人民共和国境内销售、使用的医疗器械，应当按照本规定要求附有说明书和标签。

　　第三条　医疗器械说明书是指由医疗器械注册人或者备案人制作，随产品提供给用户，涵盖该产品安全有效的基本信息，用以指导正确安装、调试、操作、使用、维护、保养的技术文件。
　　医疗器械标签是指在医疗器械或者其包装上附有的用于识别产品特征和标明安全警示等信息的文字说明及图形、符号。

　　第四条　医疗器械说明书和标签的内容应当科学、真实、完整、准确，并与产品特性相一致。
　　医疗器械说明书和标签的内容应当与经注册或者备案的相关内容一致。
　　医疗器械标签的内容应当与说明书有关内容相符合。

　　第五条　医疗器械说明书和标签对疾病名称、专业名词、诊断治疗过程和结果的表述，应当采用国家统一发布或者规范的专用词汇，度量衡单位应当符合国家相关标准的规定。

　　第六条　医疗器械说明书和标签中使用的符号或者识别颜色应当符合国家相关标准的规定；无相关标准规定的，该符号及识别颜色应当在说明书中描述。

　　第七条　医疗器械最小销售单元应当附有说明书。
　　医疗器械的使用者应当按照说明书使用医疗器械。

　　第八条　医疗器械的产品名称应当使用通用名称，通用名称应当符合国家食品药品监督管理总局制定的医疗器械命名规则。第二类、第三类医疗器械的产品名称应当与医疗器械注册证中的产品名称一致。
　　产品名称应当清晰地标明在说明书和标签的显著位置。

　　第九条　医疗器械说明书和标签文字内容应当使用中文，中文的使用应当符合国家通用的语言文字规范。医疗器械说明书和标签可以附加其他文种，但应当以中文表述为准。
　　医疗器械说明书和标签中的文字、符号、表格、数字、图形等应当准确、清晰、规范。

　　第十条　医疗器械说明书一般应当包括以下内容：
　　（一）产品名称、型号、规格；
　　（二）注册人或者备案人的名称、住所、联系方式及售后服务单位，进口医疗器械还应当载明代理人的名称、住所及联系方式；
　　（三）生产企业的名称、住所、生产地址、联系方式及生产许可证编号或者生产备案凭证编号，委托生产的还应当标注受托企业的名称、住所、生产地址、生产许可证编号或者生产备案凭证编号；
　　（四）医疗器械注册证编号或者备案凭证编号；
　　（五）产品技术要求的编号；
　　（六）产品性能、主要结构组成或者成分、适用范围；
　　（七）禁忌症、注意事项、警示以及提示的内容；
　　（八）安装和使用说明或者图示，由消费者个人自行使用的医疗器械还应当具有安全使用的特别说明；
　　（九）产品维护和保养方法，特殊储存、运输条件、方法；
　　（十）生产日期，使用期限或者失效日期；
　　（十一）配件清单，包括配件、附属品、损耗品更换周期以及更换方法的说明等；
　　（十二）医疗器械标签所用的图形、符号、缩写等内容的解释；
　　（十三）说明书的编制或者修订日期；
　　（十四）其他应当标注的内容。

　　第十一条　医疗器械说明书中有关注意事项、警示以及提示性内容主要包括：
　　（一）产品使用的对象；
　　（二）潜在的安全危害及使用限制；
　　（三）产品在正确使用过程中出现意外时，对操作者、使用者的保护措施以及应当采取的应急和纠正措施；
　　（四）必要的监测、评估、控制手段；
　　（五）一次性使用产品应当注明“一次性使用”字样或者符号，已灭菌产品应当注明灭菌方式以及灭菌包装损坏后的处理方法，使用前需要消毒或者灭菌的应当说明消毒或者灭菌的方法；
　　（六）产品需要同其他医疗器械一起安装或者联合使用时，应当注明联合使用器械的要求、使用方法、注意事项；
　　（七）在使用过程中，与其他产品可能产生的相互干扰及其可能出现的危害；
　　（八）产品使用中可能带来的不良事件或者产品成分中含有的可能引起副作用的成分或者辅料；
　　（九）医疗器械废弃处理时应当注意的事项，产品使用后需要处理的，应当注明相应的处理方法；
　　（十）根据产品特性，应当提示操作者、使用者注意的其他事项。

　　第十二条　重复使用的医疗器械应当在说明书中明确重复使用的处理过程，包括清洁、消毒、包装及灭菌的方法和重复使用的次数或者其他限制。

　　第十三条　医疗器械标签一般应当包括以下内容：
　　（一）产品名称、型号、规格；
　　（二）注册人或者备案人的名称、住所、联系方式，进口医疗器械还应当载明代理人的名称、住所及联系方式；
　　（三）医疗器械注册证编号或者备案凭证编号；
　　（四）生产企业的名称、住所、生产地址、联系方式及生产许可证编号或者生产备案凭证编号，委托生产的还应当标注受托企业的名称、住所、生产地址、生产许可证编号或者生产备案凭证编号；
　　（五）生产日期，使用期限或者失效日期；
　　（六）电源连接条件、输入功率；
　　（七）根据产品特性应当标注的图形、符号以及其他相关内容；
　　（八）必要的警示、注意事项；
　　（九）特殊储存、操作条件或者说明；
　　（十）使用中对环境有破坏或者负面影响的医疗器械，其标签应当包含警示标志或者中文警示说明；
　　（十一）带放射或者辐射的医疗器械，其标签应当包含警示标志或者中文警示说明。
　　医疗器械标签因位置或者大小受限而无法全部标明上述内容的，至少应当标注产品名称、型号、规格、生产日期和使用期限或者失效日期，并在标签中明确“其他内容详见说明书”。

　　第十四条　医疗器械说明书和标签不得有下列内容：
　　（一）含有“疗效最佳”、“保证治愈”、“包治”、“根治”、“即刻见效”、“完全无毒副作用”等表示功效的断言或者保证的；
　　（二）含有“最高技术”、“最科学”、“最先进”、“最佳”等绝对化语言和表示的；
　　（三）说明治愈率或者有效率的；
　　（四）与其他企业产品的功效和安全性相比较的；
　　（五）含有“保险公司保险”、“无效退款”等承诺性语言的；
　　（六）利用任何单位或者个人的名义、形象作证明或者推荐的；
　　（七）含有误导性说明，使人感到已经患某种疾病，或者使人误解不使用该医疗器械会患某种疾病或者加重病情的表述，以及其他虚假、夸大、误导性的内容；
　　（八）法律、法规规定禁止的其他内容。

　　第十五条　医疗器械说明书应当由注册申请人或者备案人在医疗器械注册或者备案时，提交食品药品监督管理部门审查或者备案，提交的说明书内容应当与其他注册或者备案资料相符合。

　　第十六条　经食品药品监督管理部门注册审查的医疗器械说明书的内容不得擅自更改。
　　已注册的医疗器械发生注册变更的，申请人应当在取得变更文件后，依据变更文件自行修改说明书和标签。
　　说明书的其他内容发生变化的，应当向医疗器械注册的审批部门书面告知，并提交说明书更改情况对比说明等相关文件。审批部门自收到书面告知之日起20个工作日内未发出不予同意通知件的，说明书更改生效。

　　第十七条　已备案的医疗器械，备案信息表中登载内容、备案产品技术要求以及说明书其他内容发生变化的，备案人自行修改说明书和标签的相关内容。

　　第十八条　说明书和标签不符合本规定要求的，由县级以上食品药品监督管理部门按照《医疗器械监督管理条例》第六十七条的规定予以处罚。

　　第十九条　本规定自2014年10月1日起施行。2004年7月8日公布的《医疗器械说明书、标签和包装标识管理规定》（原国家食品药品监督管理局令第10号）同时废止。

为进一步贯彻落实国务院《关于改革药品医疗器械审评审批制度的意见》和中共中央办公厅、国务院办公厅印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，落实“放管服”改革和优化营商环境要求，全面深化医疗器械审评审批制度改革，推动医疗器械产业高质量发展，更好地满足公众健康需求，现就已获进口医疗器械注册证产品在中国境内企业生产的有关事项公告如下：

一、适用范围

进口医疗器械注册人通过其在境内设立的外商投资企业在境内生产第二类、第三类已获进口医疗器械注册证产品的有关事项，适用本公告。

二、注册要求

（一）进口医疗器械注册人在中国境内设立的外商投资企业作为注册申请人，向药品监督管理部门提交境内医疗器械注册申请。注册申请内容，除注册人名称、住所、生产地址外，原则上应当与所对应的进口医疗器械注册证及其附件载明的相关事项保持一致。
　　（二）注册申请人按照《医疗器械注册申报资料要求和批准证明文件格式的公告》（国家食品药品监督管理总局2014年第43号公告）、《体外诊断试剂注册申报资料要求和批准证明文件格式的公告》（国家食品药品监督管理总局2014年第44号公告）等要求提交注册申报资料。其中，医疗器械产品的综述资料、研究资料、临床评价资料、产品风险分析资料，体外诊断试剂产品的综述资料、主要原材料的研究资料（适用时）、主要生产工艺及反应体系的研究资料（适用时）、分析性能评估资料、阳性判断值或参考区间确定资料、稳定性研究资料、临床评价资料、产品风险分析资料，可提交进口医疗器械的原注册申报资料。进口注册人和境内注册申请人应当确保上述资料与本次注册申请的相关性和支持性。
　　（三）注册申报程序按照《医疗器械注册管理办法》《体外诊断试剂注册管理办法》以及医疗器械电子申报相关规定执行。
　　（四）按照本公告要求提交注册申请并获得批准的，注册证备注栏中应当载明相关已获准注册的进口产品的医疗器械注册证号。

三、注册体系核查要求

注册申请人应当确保境内生产包含产品的主要生产工艺，并承诺主要原材料和生产工艺不发生改变，提供产品在境内生产质量管理体系符合我国《医疗器械生产质量管理规范》的自查报告和境内外质量管理体系等同性对比报告。药品监管部门按照医疗器械注册质量管理体系核查工作程序，对境内注册申请人开展全面核查，重点关注境内外质量管理体系的等同性、溯源性，以及变更生产过程带来的体系变化是否会产生新的风险，引起注册事项的变更。

四、上市后监管要求

境内注册人应当按照《医疗器械生产监督管理办法》办理医疗器械生产许可证，严格落实质量安全主体责任，加强医疗器械全生命周期质量管理；按照《医疗器械生产质量管理规范》要求，建立健全质量管理体系并保证有效运行。

五、其他方面

中国境内企业投资的境外注册人在境内生产已获进口医疗器械注册证的第二类、第三类医疗器械产品的，参照本公告执行，由投资境外注册人的中国境内企业作为注册申请人申请该产品注册。
香港、澳门、台湾地区已获医疗器械注册证的产品有关事项参照本公告执行。
本公告自公告之日起施行。

　　附件：医疗器械/体外诊断试剂注册申报资料要求

为贯彻落实党中央、国务院关于深化“放管服”改革的重要决策部署，优化营商环境，进一步激发市场主体发展活力，为企业提供更加高效便捷的政务服务，国家药监局于2020年10月试点发放国产第三类、进口第二、三类医疗器械注册证，并逐步试点发放了与电子注册证关联的注册证变更文件，现已发放医疗器械电子注册证1.4万张、注册证变更文件0.35万张。在总结前期试点发放及应用情况基础上，国家药监局经研究决定，自2022年11月1日起，全面实施医疗器械电子注册证。现将有关事项公告如下：

　　一、此次医疗器械电子注册证发放范围为自2022年11月1日起，由国家药监局批准的国产第三类、进口第二、三类医疗器械注册证及注册变更文件。

　　二、医疗器械电子注册证与纸质注册证具有同等法律效力。电子注册证具有即时送达、短信提醒、证照授权、扫码查询、在线验证、全网共享等功能。

　　三、企业须先行在国家药监局网上办事大厅注册并实名认证，进入网上办事大厅“我的证照”栏目查看下载相应的电子注册证。也可登录“中国药监APP”，查看使用电子注册证。

　　四、医疗器械电子注册证不包含产品技术要求、说明书等附件。上述附件以电子文件形式与医疗器械电子注册证同步推送至国家药监局网上办事大厅法人空间“我的证照”栏目，推送成功即送达，企业可自行登录下载获取。

　　五、申请人应妥善保管国家药监局网上办事大厅账号、电子注册证及相关附件电子文件等。

　　六、医疗器械电子注册证使用相关问题可查看国家药监局网上办事大厅“电子证照”相关栏目。

　　特此公告。

第一条　为加强医疗器械监督管理，保证医疗器械通用名称命名科学、规范，根据《医疗器械监督管理条例》，制定本规则。
　　第二条　凡在中华人民共和国境内销售、使用的医疗器械应当使用通用名称，通用名称的命名应当符合本规则。
　　第三条　医疗器械通用名称应当符合国家有关法律、法规的规定，科学、明确，与产品的真实属性相一致。
　　第四条　医疗器械通用名称应当使用中文，符合国家语言文字规范。
　　第五条　具有相同或者相似的预期目的、共同技术的同品种医疗器械应当使用相同的通用名称。
　　第六条　医疗器械通用名称由一个核心词和一般不超过三个特征词组成。
　　核心词是对具有相同或者相似的技术原理、结构组成或者预期目的的医疗器械的概括表述。
　　特征词是对医疗器械使用部位、结构特点、技术特点或者材料组成等特定属性的描述。使用部位是指产品在人体的作用部位，可以是人体的系统、器官、组织、细胞等。结构特点是对产品特定结构、外观形态的描述。技术特点是对产品特殊作用原理、机理或者特殊性能的说明或者限定。材料组成是对产品的主要材料或者主要成分的描述。
　　第七条　医疗器械通用名称除应当符合本规则第六条的规定外，不得含有下列内容：
　　（一）型号、规格；
　　（二）图形、符号等标志；
　　（三）人名、企业名称、注册商标或者其他类似名称；
　　（四）“最佳”、“唯一”、“精确”、“速效”等绝对化、排他性的词语，或者表示产品功效的断言或者保证；
　　（五）说明有效率、治愈率的用语；
　　（六）未经科学证明或者临床评价证明，或者虚无、假设的概念性名称；
　　（七）明示或者暗示包治百病，夸大适用范围，或者其他具有误导性、欺骗性的内容；
　　（八）“美容”、“保健”等宣传性词语；
　　（九）有关法律、法规禁止的其他内容。
　　第八条　根据《中华人民共和国商标法》第十一条第一款的规定，医疗器械通用名称不得作为商标注册。
　　第九条　按照医疗器械管理的体外诊断试剂的命名依照《体外诊断试剂注册管理办法》（国家食品药品监督管理总局令第5号）的有关规定执行。
　　第十条　本规则自2016年4月1日起施行。

1      Purpose of medical device classification

The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121.

2      Practical relevance of classification

The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements. The explanations provide some simplified concepts and are not exhaustive. For details see the MDR and related additional guidance2.

2.1     General requirements

Irrespective of the class of the device, all devices must comply with all relevant obligations of the MDR. However, some requirements depend on the device classification.

For example, the devices must:

• meet the general safety and performance requirements, including the requirements regarding the information to be supplied by the manufacturer (Annex I of the MDR);
• be subject to the reporting requirements under the medical device vigilance system;
• be CE marked (except custom-made devices and devices intended for clinical investigation, in which case they should comply with the provisions of respectively Art. 52.8 and Annex XIII or Articles 62 – 80, 82 and Annex XV);
• be assigned a Unique Device Identifier (UDI) number and be registered in the electronic system, in accordance with MDR Article 29;
• if the device is implantable, be supplied with an implant card and information to the patient in accordance with Article 18.

According to MDR Article 51 devices are divided into the following classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification is to be carried out in accordance with Annex VIII to the MDR. In addition, and according to Article 52(7)(a),
(b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im – measuring function and Ir – reusable surgical.

The technical documentation3 to be drawn up by the manufacturer must include the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII of the MDR.

Sections 2.2-2.6 give an overview of some requirements that depend on the class of the device. For detailed and exhaustive provisions on each topic, refer to the MDR, as well as to dedicated guidance where available4.

Annex XVI products should be classified in accordance with the classification rules in Annex VIII of the MDR and taking into account possible provisions within the relevant implementing acts covering Annex XVI devices.

2.2     Conformity assessment

Conformity assessment is the process demonstrating whether the requirements of the MDR relating to a device have been fulfilled. Demonstrating conformity is in the first instance the responsibility of the manufacturer and for most devices classes the conformity is then assessed by a notified body. The higher the class of the device, the greater the involvement of a notified body in conformity assessment. Annex I (general safety and performance requirements) and Annexes II (technical documentation) and III (technical documentation on post-market surveillance) apply to all devices regardless of class. Further relevant conformity assessment procedures (laid down in Annexes IX to XI) will depend on the class of the device. For some classes, the manufacturer has a choice of more than one procedure. Conformity assessment is described in MDR Article 52.

Custom-made or investigational devices falling into any class have their own provisions: Annex XIII for custom-made devices and Article 82 for investigational devices. For class III implantable custom-made devices, the manufacturer also needs to apply either Chapter I of Annex IX or Part A of Annex XI.

2.3     Clinical evaluation and investigation

For any device regardless of class, the manufacturer must ensure the general safety and performance requirements are satisfied (MDR Article 5, MDR Annex I). This includes carrying out a clinical evaluation (MDR Article 5 (3), MDR Article 61, MDR Annex XIV. For implantable devices and class III devices, a premarket clinical investigation is compulsory, with some exceptions such as modifications of an existing device, demonstrated equivalence to CE-marked device, placed on the market under Directive 90/385/EEC or Directive 93/42/EEC for which sufficient clinical data is already available, and specific exemptions laid down in Article 61(6)(b). The conditions for starting a clinical investigation vary depending on the class of the device (see MDR Article 70(7) and Article 78). According to Article 61(10), if demonstration of conformity with Annex I requirements based on clinical data is not deemed appropriate, the manufacturer shall justify this in the technical documentation.

For class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, the notified body must also follow the clinical evaluation consultation procedure where certain documentation including the clinical evaluation report is submitted for review by expert panels (MDR Article 54 and Section 5.1 of Annex IX). It must notify the Member State competent authorities of the certificates it has granted for these types of devices (MDR Article 55). The manufacturer may consult an expert panel on their clinical development strategy prior to performing the clinical evaluation and/or investigation (MDR Article 61(2)). See also MDCG Guideline 2019-35 for interpretation of Article 54.

For implantable devices and class III devices, other than custom-made or investigational devices, the manufacturer must update the post- market clinical follow-up evaluation report as it will serve an input for the writing of the Periodic Safety Update Report, and, if indicated, the summary of safety and clinical performance6 (MDR Article 32).

2.4     Post-market surveillance

The manufacturer must update the clinical evaluation with clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.

For class I devices, including sterile, those with a measuring function and the reusable surgical instruments, the manufacturer must prepare and maintain a post-market surveillance report (MDR Article 85), which must be made available to the competent authorities on request.

For class IIa, IIb and III devices, the manufacturer must prepare a periodic safety update report for each device, and, where relevant, for each category or group of devices (MDR Article 86). This report must be updated at least annually for class IIb and III devices and at least every two years for class IIa devices.

2.5     Traceability

For class III implantable devices, economic operators and health institutions are obliged to have a record of the UDI of the devices they have supplied or with which they have been supplied (MDR Article 27).

For class II and III devices, the economic operator is obliged to provide information on the Member State(s) where the device is, or is to be, made available when registering the device (Annex VI Part A 2.4). In the case of implantable and class III devices, the economic operator must provide the summary of safety and clinical performance (Annex VI Part A 2.14). For single-use class I and IIa devices packaged and labelled individually, the UDI carrier does not have to appear on the packaging but must appear on a higher level of packaging (Annex VI Part C 4.3).

However, if the healthcare provider does not have access to the higher level of packaging, the UDI carrier must appear on the individual device packaging.

2.6     Instructions for use

Generally, instructions for use must be supplied together with the device. By way of exception, class I and IIa devices may be supplied without instructions for use if such devices can safely be used without the instructions and no other provisions of Annex I Section 23 state otherwise.

3     How to carry out classification

This section is aimed at presenting definitions and terms useful for the application of the classification principles and rules.

3.1     Basic terms and definitions

Relevant definitions in respect to the classification of devices are set out in Article 2 and Chapter I of Annex VIII of the MDR but the Regulation also contains explanation of further terms. These relevant terms and definitions for this guidance are collected below.

3.1.1 Specific medical purpose

The specific medical purpose is specified by the manufacturer from those listed in the indents of Article 2(1) MDR.

3.1.2 Duration of use

Transient: Normally intended for continuous use for less than 60 minutes.

Short term: Normally intended for continuous use for between 60 minutes and 30 days_._

Long term: Normally intended for continuous use for more than 30 days.

In certain instances the duration of use for a product needs to be considered as the duration of effect. For instance, application of a topical cream to the skin may only take seconds to apply but the cream may remain in situ for many hours. The duration of use should therefore not be considered as the time taken to apply the product but rather the duration for which the product remains in or on the body.

3.1.3 Continuous use

In calculating the duration referred to in Section 1 of Chapter I of Annex VIII of MDR, continuous use means:

‘(a) The entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and

(b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.’

For example, a scalpel may be used on the same patient throughout an operation that may last for several hours. The uninterrupted use for an intended purpose, i.e. cutting tissue, will normally not last for more than a few seconds at a time. Therefore a scalpel is a transient use device. However, where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device (e.g. replacement of a ureteric catheter) this shall be considered an extension of the continuous use of the device.

As another example, the overnight period when contact lenses are cleaned and disinfected is considered as a discontinuation of the device use. For the determination of the duration of use, only the specified time period of uninterrupted wear of the lens (e.g. 16 hours) needs to be taken into account7.

If it cannot be demonstrated that components of the device are totally discontinued in the interval between uses, this is also considered as an immediate replacement and an extension of the continuous use of the device.

3.1.4 Invasiveness

Invasive device:
Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. A device that administers energy to the body should not be considered as invasive if only energy it emits penetrates the body and not the device itself.

Body orifice:
Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Injured skin or mucous membrane:
An area of skin or a mucous membrane presenting a pathological change or change following disease, a wound or a scar.

Surgically invasive device:
An invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and a device which produces penetration other than through a body orifice.

The term surgical operation used in this definition includes all clinical interventional procedures in which a device is placed into the body through the surface of the body. A surgically invasive device always implies that it enters through an artificially created opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening made by a needle. Therefore surgical gloves and needles used with syringes are surgically invasive.

In this context the following should be noted:

• a surgically created stoma used in urostomy, colostomy and ileostomy or permanent tracheostomy is considered to be a body orifice; therefore devices introduced into such a stoma are not surgically invasive.
• in contrast, a surgically created opening to allow access to the circulatory system should not be considered to be a body orifice. Devices introduced into such an opening are surgically invasive.

The concept of surgically invasive should be understood to cover also liquids that are in invasive contact with organs, tissues or other parts of the body if the access for such liquids is through a surgically created opening.

For a device that administers a substance, such a substance must be assessed in its own right (e.g. substances administered by a jet injector).

Reusable surgical instrument:
An instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

Implantable device:
Any device, including those that are partially or wholly absorbed, which is intended:
—   to be totally introduced into the human body, or
—  to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

A ‘procedure’ must be understood in this context to include the surgical procedure during which the implant is placed into the body and the immediate post-operative care that is associated with the procedure. The ‘procedure’ does not extend to the conclusion of the therapeutic treatment, e.g. the removal of an implant must be considered to be another ‘procedure’. Thus a plate used to fix a fractured bone and which remains in place after the procedure for at least 30 days is an implant even if it is taken out after the fracture has healed. In this case the placing of the plate and its explantation are two different surgical procedures.

Sometimes partially implanted devices are deemed to be implants. For instance, if an operation is carried out specifically to place an infusion port into the body which would remain in place for at least 30 days after the procedure, such an infusion port would be an implant. However, a non-tunnelled central venous catheter which is intended for use for temporary vascular access and intended to be removed after 7 – 10 days is not an implantable device. Nor would a suture used for skin wound closure that is intended to be taken out prior to 30 days be considered an implant.

Critical anatomical locations:
For the purposes of the MDR, ‘Central circulatory system’ means the following blood vessels:

arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.

For the purposes of the MDR, ‘Central nervous system’ means the brain, meninges and spinal cord.

3.1.5 Active medical devices

Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

The concept act by converting energy includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues. Electrodes intended for E.C.G. or E.E.G are normally not considered active devices because they do not normally act by conversion of energy.

The application of energy from the human body for the purpose of operating a device does not make the device ‘active’ unless that energy is stored within the device for subsequent release. For instance, energy generated by human muscle and applied to the plunger of a syringe (thus causing a substance to be delivered to a patient) does not make this syringe an active device. However, if a drug delivery system depends upon manual winding to preload a spring which is subsequently released to deliver a substance, then the device incorporating the spring is an active device. Another example of an active device are elastomeric pumps, where the energy from the human body is stored in the stretched elastomer layer.

Medical devices using prestored gases and/or vacuum as a power source are regarded as active devices, as long as they fulfil both the criteria under the definition e.g. gas mixers with anaesthesia machines, aerosol pain relief sprays with a pre-stored propellant gas supply and gas-powered suction pumps.

Heating/cooling pads intended only to release stored thermal energy are not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. exothermic or endothermic reaction) are active devices as they are converting chemical energy into heat and/or vice versa.

The concept of significant change for energy includes changes in the nature, level and density of energy (see Rule 9). This means that for instance an electrode is not considered an active device under this classification system as long as the energy input is intended to be the same as the energy output. Resistance in a wire that causes minor changes between input and output cannot be considered to constitute ‘significant change’. However, electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue.

Software is also an active device. Software should be reviewed not only in the context of Rule 11.

Active therapeutic device means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question itself or when it provides decisive information for the diagnosis.

3.1.6 Devices with a measuring function

The following criteria, if fulfilled together, indicate that a device has a measuring function:

a)  The device is intended by the manufacturer to measure:
–  quantitatively a physiological or anatomical parameter, or
–  a quantity or a quantifiable characteristic of energy or of substances (including medicinal products) delivered to or removed from the human body. Spoons or plastic syringes co-packed with medicinal products and used to measure a quantity of that medicinal product to be administered to the patient are in this category. Devices for the delivery of liquid to the human body without graduation or scale (e.g. medicine spoons, cups, droppers without graduation or scale or display of measuring unit) are not in this category.

b)   The result of the measurement:
–  is displayed in legal units or other acceptable units within the meaning of Directive 80/181/ECC20, or
–  is compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the mentioned directive..

c)   The intended purpose implies accuracy, claimed explicitly or implicitly, where a non-compliance with the implied accuracy could result in a significant adverse effect on the patient’s health and safety.

The expression claimed implicitly covers cases where the user, on the basis of the designation of the device or of its accompanying documents, or on the basis of the common use, is entitled to expect accuracy where the accuracy of the measurement has an impact on the diagnosis or therapy of the patient.

Measuring activities during the manufacturing process including those for calibration purposes are not covered and do not imply a measuring function of the manufactured device.

3.1.7 Systems and procedure packs

System and procedure packs is described in MDR Article 22. They can combine medical devices, in vitro diagnostic medical devices, and other products which are in conformity with legislation that applies to those products, only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified. In this case of demonstrated legal conformity of each component, the systems or procedure packs no not need to bear themselves an additional CE marking but they must bear the name, registered trade name or registered trade mark of the person who combines the products as well as the address at which that person can be contacted.

A procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose. A system means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer’s instructions the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to MDR Article 52. The classification is determined by the intended use of the system or procedure pack. The natural or legal person that combines the devices must assume the obligations incumbent on manufacturers.

For such combinations, including different devices, the classification is normally determined by the intended use. In those cases where the intended use of the final device is not specific enough to determine the classification, the classification of the device is at the level of the highest classified device included, taking into account the new intended use of the device.

3.1.8 Other terms

This section gives notes on other terms used in Annex VIII of the MDR:

Systemic absorption: The process by which substances or their metabolites enter the body (e.g. by crossing mucous membranes) and are distributed into the body via the blood and/or lymphatic system.

Wholly or mainly absorbed: The term ‘absorption’ in the context of implantable devices refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. It does not apply to those substances that are excreted without modification from the body, e.g. insufflation gases for the abdominal cavity or laparoscopic and endoscopic procedures.

Local dispersion: The condition by which substances remain in a specific site without being distributed into the body via the blood and/or lymphatic system.

Medicine / medicinal product: According to the definition given in Directive 2001/83/EC:

‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

A ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials according to MDR, Article 2(18). Related definitions on ‘particle’, ‘agglomerate’ and ‘aggregate’ are also included in the MDR Article 2(19-21). The definitions on nanomaterial and the related terms were taken from Commission Recommendation 2011/696/EU on the definition of nanomaterials23. Guidance on terms and concepts used in the definition can be found in a report from the European Commission’s Joint Research Centre.24

Derivative means a non-cellular substance extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.

3.2     Application of the classification rules

Before applying the classification rules, the manufacturer should first determine if the product concerned, based on its specific medical purpose, falls in the scope of the MDR as medical device, accessory for a medical device (Article 2 MDR), medical device part or component for replacement (Article 23(2) MDR) or as a device without an intended medical purpose listed in Annex XVI.

It is the intended and not the accidental use of the device that determines the class of the device. For instance, a suture organiser that is intended to keep suture threads used in open heart surgery in the correct order should not be considered as an invasive device if it is intended to be kept outside the patient. Similarly, if a healthcare professional or others uses the device in a manner not intended by the manufacturer, this does not change the class of the device for the purpose of conformity assessment. However, if the normal clinical use of the device changes in time with evolving clinical practice such that the intended purpose and classification of the device changes, this should be addressed by the manufacturer and the conformity of the device assessed for the new intended purpose. It is the intended purpose assigned by the manufacturer to the device that determines the class of the device and not the class assigned to other similar products. For instance, two sutures that have the same composition may well have different intended purposes.

In case several rules, or if, within the same classification rule, several sub-rules, apply to the same device based on the device intended purpose, the strictest rule and sub-rule resulting in higher classification will apply.

In terms of further clarification of the classification rules, the elements listed below should also be considered.

3.2.1 How to use the rules

The manufacturer must take into consideration all the rules in order to establish the proper classification for its device. The strictest rule and sub-rule resulting in the highest classification determines the class25. It is quite conceivable for instance that one of the general rules that is not specific to active devices nevertheless applies to such a device. The intended purpose and all the device characteristics must be taken into consideration. The characteristic or combination of characteristics in accordance with the intended purpose of the device that falls into the highest class determines the class for the device as a whole.

In addition to the classification rules set out in Annex VIII of MDR, the manufacturers must also take account of any applicable legal acts and consider guidance documents which may support the classification of their device.

3.2.2 Practical example

A simple wound drainage system has usually three components that must be taken into consideration: the cannula, the tubing and the collector unit. If the system is sold without a cannula, then the classification of the cannula does not need to be taken into account. It is assumed here that the system is used for short term duration, i.e. that uninterrupted intended use is more than 60 minutes and less than 30 days. It is furthermore assumed that the collected liquids are not intended to be reinfused into the body nor reprocessed for eventual reinfusion and that the device is not intended to be connected to a powered suction system.

Intended uses	Rule	Class
Surgically invasive cannula to reach a wound site in the pleural cavity to drain the cavity	7	IIa
Non-invasive tubing to evacuate body liquids towards the collector.	1	I
Non-invasive collector to receive the body liquids.	1	I

The clear conclusion here is that the manufacturer would have a choice of applying class IIa to the whole device or carrying out separate conformity assessment procedures for the cannula on one hand and the tubing and collector on the other hand.

3.3     Handling of interpretational problems

It is recognised that although the existing rules will adequately classify the vast majority of existing devices, a small number of devices may be more difficult to classify.

As soon a notified body needs to be involved, any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, may be referred for a decision to the competent authority of the Member State in which the manufacturer (or its authorized representative) has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority must adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business will notify the MDCG and the Commission of its decision. The decision can be made available upon request.

Outside this regulatory procedure, competent authorities may refer on an ad hoc and voluntary basis complex classification cases for discussion at the Borderline and Classification Working Group of the MDCG. Agreement positions on classification reached by this Working Group are published for reference in the Manual on Borderline and Classification.

中文翻译

1 医疗器械分类的目的

欧盟医疗器械法规采用的医疗器械分类系统是一个基于风险的体系,考虑了人体的脆弱性以及与器械相关的潜在风险。该方法使用一系列可以以不同方式组合的标准来确定分类,例如与人体接触的持续时间、侵入程度、局部与系统性作用、潜在毒性、器械使用影响的身体部位以及器械是否依赖能量源。这些标准可以应用于各种不同的医疗器械和技术。这些被称为”分类规则”,在医疗器械法规(EU) 2017/745 (MDR)附录VIII中有详细规定。这些规则在很大程度上与国际医疗器械监管者论坛(IMDRF)在指导文件GHTF/SG1/N77:2012中制定的分类规则相对应。

2 分类的实际意义

本章的目的是概述医疗器械分类对器械合规性各个方面的影响。这些解释提供了一些简化的概念,并非详尽无遗。详细内容请参见MDR及相关补充指南。

2.1 一般要求

无论器械属于哪个类别,所有器械都必须符合MDR的所有相关义务。但是,某些要求取决于器械的分类。

例如,器械必须:

• 满足通用安全和性能要求,包括制造商提供信息的要求(MDR附录I);
• 遵守医疗器械警戒系统下的报告要求;
• 加贴CE标志(定制器械和用于临床研究的器械除外,这些器械应分别遵守第52.8条和附录XIII或第62-80条、第82条和附录XV的规定);
• 根据MDR第29条分配唯一器械标识(UDI)号码并在电子系统中注册;
• 如果是植入性器械,则必须根据第18条提供植入卡和患者信息。

开始临床研究的条件因器械类别而异(参见MDR第70(7)条和第78条)。根据第61(10)条,如果认为基于临床数据证明符合附录I要求不适当,制造商应在技术文件中说明理由。

对于III类植入性器械和用于给药或去除药物的IIb类有源器械,公告机构还必须遵循临床评价咨询程序,将包括临床评价报告在内的某些文件提交专家小组审查(MDR第54条和附录IX第5.1节)。公告机构必须将其为这些类型器械颁发的证书通知成员国主管部门(MDR第55条)。制造商可以在进行临床评价和/或研究之前就其临床开发策略咨询专家小组(MDR第61(2)条)。另请参见MDCG指南2019-3关于第54条的解释。

对于植入性器械和III类器械(定制或研究用器械除外),制造商必须更新上市后临床跟踪评价报告,因为它将作为编写定期安全更新报告的输入,并在需要时用于编写安全和临床性能总结(MDR第32条)。

2.4 上市后监督

制造商必须使用来自上市后监督的临床相关信息更新临床评价,特别是上市后临床跟踪。

对于I类器械(包括无菌、具有测量功能和可重复使用手术器械),制造商必须准备并维护上市后监督报告(MDR第85条),该报告必须根据要求提供给主管部门。

对于IIa类、IIb类和III类器械,制造商必须为每个器械以及相关的每个类别或组别准备定期安全更新报告(MDR第86条)。对于IIb类和III类器械,该报告必须至少每年更新一次,对于IIa类器械,必须至少每两年更新一次。

2.5 可追溯性

对于III类植入性器械,经济运营商和医疗机构有义务记录其供应或接收的器械的UDI(MDR第27条)。

对于II类和III类器械,经济运营商在注册器械时有义务提供器械在或将在哪些成员国可获得的信息(附录VI A部分2.4)。对于植入性和III类器械,经济运营商必须提供安全和临床性能总结(附录VI A部分2.14)。对于单独包装和标签的一次性I类和IIa类器械,UDI载体不必出现在包装上,但必须出现在更高级别的包装上(附录VI C部分4.3)。

然而,如果医疗机构无法获得更高级别的包装,则UDI载体必须出现在单个器械包装上。

2.6 使用说明

通常,使用说明必须随器械一起提供。作为例外,如果I类和IIa类器械无需使用说明即可安全使用,且附录I第23节未规定其他要求,则可以不提供使用说明。

3 如何进行分类

本节旨在介绍用于应用分类原则和规则的定义和术语。

3.1 基本术语和定义

与器械分类相关的定义在MDR第2条和附录VIII第I章中规定,但该法规还包含其他术语的解释。以下收集了与本指南相关的术语和定义。

3.1.1 特定医疗用途

特定医疗用途由制造商从MDR第2(1)条列出的用途中指定。

3.1.2 使用时间

短暂性：通常用于连续使用不超过60分钟。 短期：通常用于连续使用60分钟至30天之间。 长期：通常用于连续使用超过30天。

在某些情况下,需要将产品的使用时间视为效果持续时间。例如,在皮肤上涂抹局部乳膏可能只需要几秒钟,但乳膏可能会在原位停留多个小时。因此,使用时间不应被视为涂抹产品所需的时间,而应是产品在体内或体表停留的时间。

3.1.3 连续使用

在计算MDR附录VIII第I章第1节所述的持续时间时,连续使用是指：

“(a) 同一器械的整个使用时间,不考虑在程序中暂时中断使用或为清洁或消毒器械而暂时移除。使用中断或器械移除是否为暂时性,应根据中断或移除前后的使用时间来确定；以及

(b) 制造商预期立即用同类型器械替换的器械的累计使用时间。”

例如,手术刀可能在整个手术过程中用于同一患者,手术可能持续数小时。但用于预期目的(即切割组织)的不间断使用通常每次只持续几秒钟。因此手术刀是短暂使用器械。然而,当器械的使用被中断是为了立即用相同或相同类型的器械替换时(例如更换输尿管导管),这应被视为器械连续使用的延续。

另一个例子是,在夜间清洁和消毒隐形眼镜的时间被视为器械使用的中断。在确定使用时间时,只需要考虑镜片不间断佩戴的指定时间段(例如16小时)。

如果无法证明器械的组件在使用间隔期间完全停止使用,这也被视为立即替换和器械连续使用的延续。

3.1.4 侵入性

侵入性器械： 任何完全或部分通过体表或体腔开口进入人体的器械。如果器械只向人体传递能量而器械本身不进入人体,则不应被视为侵入性器械。

体腔开口： 任何自然的身体开口,以及眼球外表面,或任何永久性人工开口,如造口。

受损的皮肤或粘膜： 由于病理改变或疾病、创伤或疤痕而发生改变的皮肤或粘膜区域。

手术侵入性器械： 通过体表(包括通过体腔开口的粘膜)在手术操作的帮助下或在手术操作环境中进入体内的侵入性器械；以及通过非体腔开口方式产生穿透的器械。

本定义中使用的手术操作一词包括所有通过体表将器械置入体内的临床介入程序。手术侵入性器械总是意味着它通过人工创建的开口进入。这可以是大开口,如手术切口,也可以是针头造成的针刺开口。因此,手术手套和注射器用针都是手术侵入性器械。

在这种情况下,应注意以下几点：

• 用于尿路造口、结肠造口和回肠造口或永久性气管造口的外科造口被视为体腔开口；因此,通过此类造口引入的器械不是手术侵入性器械。
• 相反,为接触循环系统而外科创建的开口不应被视为体腔开口。通过此类开口引入的器械是手术侵入性器械。

如果通过外科创建的开口与器官、组织或身体其他部位进行侵入性接触的液体,也应理解为手术侵入性的概念。

对于给药器械,此类物质必须单独评估(例如,通过喷射注射器给药的物质)。

可重复使用手术器械： 用于手术切割、钻孔、锯切、刮削、刮擦、夹持、牵开、夹夹或类似程序的器械,不与有源器械连接,且制造商预期在进行适当的清洁、消毒和灭菌等程序后可重复使用。

植入性器械： 任何预期：

• 完全引入人体内,或
• 通过临床干预替代上皮表面或眼球表面, 并在手术后保持原位的器械,包括那些部分或完全被吸收的器械。

任何通过临床干预部分引入人体并预期在手术后保持原位至少30天的器械也应被视为植入性器械。

在这种情况下,”手术”必须理解为包括植入物放置入体内的手术程序和与该程序相关的直接术后护理。”手术”不延伸到治疗结束,例如,取出植入物必须被视为另一次”手术”。因此,用于固定骨折的钢板在手术后保持原位至少30天是植入物,即使在骨折愈合后将其取出。在这种情况下,放置钢板和取出钢板是两个不同的手术程序。

有时部分植入的器械被视为植入物。例如,如果专门进行手术以放置输液港并在手术后保持原位至少30天,这样的输液港就是植入物。然而,用于临时血管通路且预期在7-10天内移除的非隧道中心静脉导管不是植入性器械。同样,用于皮肤伤口闭合且预期在30天前取出的缝线也不被视为植入物。

重要解剖位置： 就MDR而言,”中央循环系统 “指以下血管： 肺动脉、升主动脉、主动脉弓、降主动脉至主动脉分叉、冠状动脉、颈总动脉、颈外动脉、颈内动脉、大脑动脉、头臂干、心脏静脉、肺静脉、上腔静脉和下腔静脉。

就MDR而言,”中枢神经系统 “指大脑、脑膜和脊髓。

3.1.5 有源医疗器械

有源器械 指其运行依赖于非人体为该目的产生的能量源或重力的任何器械,其通过改变能量密度或转换该能量来发挥作用。在有源器械和患者之间传输能量、物质或其他元素而不发生任何显著变化的器械不应被视为有源器械。

通过转换能量 的概念包括器械内的能量转换和/或器械与组织之间界面或组织内的能量转换。用于心电图或脑电图的电极通常不被视为有源器械,因为它们通常不通过能量转换起作用。

使用人体能量来操作器械不会使器械成为”有源”器械,除非该能量被储存在器械中以供后续释放。例如,由人体肌肉产生并施加于注射器活塞的能量(从而导致物质输送给患者)不会使该注射器成为有源器械。然而,如果药物输送系统依赖手动上弦来预加载弹簧,随后释放以输送物质,则包含该弹簧的器械是有源器械。另一个例子是弹性泵,其中人体能量储存在拉伸的弹性层中。

使用预储存气体和/或真空作为动力源的医疗器械 被视为有源器械,只要它们满足定义下的两个标准,例如麻醉机的气体混合器、带有预储存推进气体的气雾剂止痛喷雾和气动吸引泵。

仅用于释放储存热能的加热/冷却垫不是有源器械,因为它们不通过能量转换起作用。然而,通过化学作用(例如放热或吸热反应)工作的加热/冷却垫是有源器械,因为它们将化学能转换为热能和/或反之。

显著变化 的概念包括能量性质、水平和密度的变化(参见规则9)。这意味着例如,电极在这个分类系统下不被视为有源器械,只要能量输入与能量输出相同。导线中导致输入和输出之间微小变化的电阻不能被视为”显著变化”。然而,用于切割组织或电凝的电外科电极是有源器械,因为它们的运行依赖于发生器提供的能量,其作用是通过器械与组织之间界面或组织中的能量转换实现的。

软件 也是有源器械。软件不应仅在规则11的背景下进行审查。

有源治疗器械 指单独使用或与其他器械组合使用的任何有源器械,用于支持、修改、替代或恢复生物功能或结构,以治疗或缓解疾病、损伤或残疾。

用于诊断和监测的有源器械 指单独使用或与其他器械组合使用的任何有源器械,用于提供信息以检测、诊断、监测或治疗生理状况、健康状态、疾病或先天性畸形。当器械本身提供疾病或状况的诊断,或提供决定性的诊断信息时,被认为允许直接诊断。

3.1.6 具有测量功能的器械

以下标准如果同时满足,表明器械具有测量功能：

a) 制造商预期该器械用于测量：

• 生理或解剖参数的定量值,或
• 输送到人体或从人体移除的能量或物质(包括药品)的数量或可量化特征。与药品共同包装并用于测量要给予患者的该药品数量的勺子或塑料注射器属于此类。用于向人体输送液体但没有刻度或刻度尺(例如无刻度或刻度尺或测量单位显示的药用勺、杯、滴管)的器械不属于此类。

b) 测量结果：

• 以法定单位或指令80/181/ECC20含义内的其他可接受单位显示,或
• 与以上述指令规定的法定单位或其他可接受单位表示的至少一个参考点进行比较。

c) 预期用途暗示明确或隐含的准确性,如果不符合隐含的准确性可能导致患者健康和安全的重大不良影响。

隐含声称 这一表述涵盖了这样的情况：用户基于器械的名称或其随附文件,或基于通常使用,有权期望准确性,而测量的准确性会影响患者的诊断或治疗。

制造过程中的测量活动,包括用于校准目的的活动,不包括在内,也不意味着制造的器械具有测量功能。

3.1.7 系统和手术包

系统和手术包在MDR第22条中有描述。它们可以组合医疗器械、体外诊断医疗器械和符合适用于这些产品的法规的其他产品,但前提是这些产品仅在医疗程序中使用或其在系统或手术包中的存在是合理的。在每个组件都证明具有法律合规性的情况下,系统或手术包本身不需要额外的CE标志,但必须标明组合产品的人的名称、注册商标或注册商号以及可联系到该人的地址。

手术包 是指为特定医疗目的而一起包装并投放市场的产品组合。系统 是指为实现特定医疗目的而预期互连或组合的产品组合,这些产品可以一起包装,也可以不一起包装。

如果系统或手术包包含未加贴CE标志的器械,或者所选择的器械组合就其原始预期用途而言不兼容,或者灭菌未按照制造商的说明进行,则该系统或手术包应被视为一个独立的器械,并应根据MDR第52条进行相关符合性评估程序。分类由系统或手术包的预期用途决定。组合器械的自然人或法人必须承担制造商的义务。

对于包括不同器械的此类组合,分类通常由预期用途决定。在最终器械的预期用途不足以确定分类的情况下,器械的分类应考虑新的预期用途,取决于所包含的最高分类器械的级别。

3.1.8 其他术语

本节说明MDR附录VIII中使用的其他术语：

系统性吸收 ：物质或其代谢物进入体内(例如,通过粘膜)并通过血液和/或淋巴系统分布到体内的过程。

完全或主要被吸收 ：”吸收”一词在植入性器械的背景下指材料在体内的降解以及通过体内代谢清除降解产物。它不适用于未经改变从体内排出的物质,例如用于腹腔或腹腔镜和内窥镜手术的充气气体。

局部扩散 ：物质保持在特定部位而不通过血液和/或淋巴系统分布到体内的状态。

药物/药品 ：根据指令2001/83/EC给出的定义： “(a) 任何被描述为具有治疗或预防人类疾病特性的物质或物质组合；或 (b) 任何可用于或施用于人体的物质或物质组合,其目的是通过发挥药理学、免疫学或代谢作用来恢复、纠正或改变生理功能,或进行医学诊断。”

“纳米材料“指含有以非结合状态、聚集体或团聚体形式存在的颗粒的天然、偶然产生或人工制造的材料,其中按数量粒径分布计,50%或以上的颗粒在一个或多个外部尺寸上处于1-100纳米范围内；富勒烯、石墨烯片和单壁碳纳米管在一个或多个外部尺寸小于1纳米时也应被视为纳米材料,根据MDR第2(18)条。相关的”颗粒”、”团聚体”和”聚集体”定义也包含在MDR第2(19-21)条中。关于纳米材料和相关术语的定义来自欧盟委员会建议2011/696/EU。关于定义中使用的术语和概念的指导可以在欧盟委员会联合研究中心的报告中找到。

衍生物 指通过制造过程从人体或动物组织或细胞中提取的非细胞物质。在这种情况下,用于制造器械的最终物质不含任何细胞或组织。

3.2 分类规则的应用

在应用分类规则之前,制造商应首先根据其特定医疗用途确定相关产品是否属于MDR范围内的医疗器械、医疗器械配件(MDR第2条)、用于更换的医疗器械部件或组件(MDR第23(2)条)或附录XVI中列出的无医疗用途的器械。

决定器械类别的是器械的预期用途而不是意外使用。例如,如果用于开心手术的缝线整理器预期保持在患者体外以保持缝线的正确顺序,则不应被视为侵入性器械。同样,如果医疗专业人员或其他人以制造商未预期的方式使用器械,这不会改变器械用于符合性评估的类别。然而,如果器械的正常临床使用随着临床实践的发展而随时间改变,以致器械的预期用途和分类发生变化,制造商应对此进行处理,并对器械进行新预期用途的符合性评估。决定器械类别的是制造商为器械指定的预期用途,而不是分配给其他类似产品的类别。例如,两种具有相同成分的缝线可能具有不同的预期用途。

如果基于器械的预期用途,同时适用多个规则,或者在同一分类规则内适用多个子规则,则应适用导致更高分类的最严格规则和子规则。

关于分类规则的进一步说明,还应考虑以下列出的要素。

3.2.1 如何使用规则

制造商必须考虑所有规则以确定其器械的适当分类。导致最高分类的最严格规则和子规则决定类别。例如,完全可以想象一个不特定于有源器械的一般规则仍然适用于这样的器械。必须考虑预期用途和器械的所有特征。符合预期用途的特征或特征组合中属于最高类别的特征决定器械整体的类别。

除了MDR附录VIII中规定的分类规则外,制造商还必须考虑任何适用的法律文件,并考虑可能支持其器械分类的指导文件。

3.2.2 实际示例

一个简单的伤口引流系统通常有三个必须考虑的组件：套管、导管和收集单元。如果系统不带套管销售,则不需要考虑套管的分类。这里假设系统用于短期使用,即不间断预期使用时间超过60分钟但少于30天。此外假设收集的液体不打算重新输注到体内或重新处理以便最终重新输注,且器械不打算连接到动力抽吸系统。

预期用途规则类别	规则	分类
手术侵入性套管到达胸腔伤口部位以引流腔体	7	IIa
非侵入性导管将体液排向收集器	1	I
非侵入性收集器接收体液	1	I

这里的明确结论是,制造商可以选择将IIa类应用于整个器械,或者对套管和导管及收集器分别进行符合性评估程序。

3.3 解释问题的处理

认识到虽然现有规则将充分对大多数现有器械进行分类,但少数器械可能更难分类。

一旦需要公告机构参与,制造商与相关公告机构之间因适用附录VIII而产生的任何争议,可提交给制造商(或其授权代表)注册地所在成员国的主管部门作出决定。如果制造商在欧盟没有注册地且尚未指定授权代表,此事项应提交给附录IX第2.2节第二段(b)项最后一段所述授权代表注册地所在成员国的主管部门。如果相关公告机构设在制造商所在成员国以外的其他成员国,主管部门必须在咨询指定该公告机构的成员国主管部门后作出决定。制造商注册地所在成员国的主管部门应将其决定通知MDCG和委员会。该决定可根据要求提供。

在这个监管程序之外,主管部门可以在自愿的特别基础上将复杂的分类案例提交给MDCG的边界和分类工作组讨论。该工作组就分类达成的一致意见将发布在《边界和分类手册》中供参考。

MDCG 2021-24 Guidance on classification of medical devices

Non-invasive devices

Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin1 only

General explanation of the rule

This is a fall-back rule applying to all devices that are not covered by a more specific rule.

This is a rule that applies in general to devices that come into contact only with intact skin or that do not come in direct contact with the patient.

Class	Rule 1	Examples
I	All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies	– Devices intended in general for external patient support (e.g. hospital beds, patient hoists, walking aids, wheelchairs, stretchers, dental patient chairs) – Body liquid collection devices intended to be used in such a way that a return flow is unlikely (e.g. to collect body wastes such as urine collection bottles, incontinence pads or collectors used with wound drainage devices). They may be connected to the patient by means of catheters and tubing – Devices used to immobilise body parts and/or to apply force or compression on them (e.g. non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery) – Corrective spectacle frames (i.e. glasses) and lenses in frames – Stethoscopes – Eye occlusion plasters – Incision drapes – Non-invasive conductive gels i.e. ultrasound gels – Non-invasive electrodes (electrodes for EEG or ECG) – Permanent magnets for removal of ocular debris – Wheelchairs pushed by hand

Practical issues of classification

Some non-invasive devices are indirectly in contact with the body and can influence internal physiological processes by storing, channelling or treating blood, other body liquids or liquids which are returned or infused into the body or by generating energy that is delivered to the body. These are handled by other rules because of the hazards inherent in such indirect influence on the body.

Note 1: Intact skin includes the skin around an established stoma unless the skin is breached. Signs of breached skin include, but not limited to, tears, erythema, oedema, weeping and infection. The definition of intact skin must apply for the continuous use of the device.

Note 2: Ultrasound gels are not to be absorbed or locally dispersed within the body at the site of action in order to achieve their intended purpose.

Rule 2 – Channelling or storing for eventual administration

General explanation of the rule

This rule applies to non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for specific purposes. Invasive devices, other than surgically invasive devices which are intended to administer medicinal products by inhalation, fall under the Rule 20

These types of devices should be considered separately from the non-contact devices of Rule 1 because they may be indirectly invasive. They channel or store substances that will eventually be administered to the body. Typically these devices are used in transfusion, infusion, extracorporeal circulation and delivery of anaesthetic gases and oxygen.

In some cases devices covered under this rule are very simple delivery devices that rely on gravity.

Class	Rule 2	Examples
IIa	All non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa: – if they may be connected1 to a class IIa, class IIb or class III active device; or if they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues,	·         Devices intended to be used as channels in active drug delivery systems, e.g. tubing intended for use with an infusion pump ·         Devices used for channelling gases, e.g. antistatic tubing for anaesthesia, anaesthesia breathing circuits ·         Syringes for infusion pumps ·         Devices intended to channel blood (e.g. in transfusion, extracorporeal circulation) ·         Devices intended for temporary storage and transport of organs for transplantation (i.e. containers, bags) ·        Devices intended for long term storage of biological substances and tissues such as corneas, sperm, human embryos, etc. (i.e. containers, bags) ·         Fridges/freezers specifically intended for storing blood, tissues etc. ·         Tubings/blood lines for extracorporeal treatment (dialysis and apheresis therapies)
IIb	– except for blood bags; blood bags are classified as class IIb.	·         Blood bags without a substance which, if used separately, can be considered to be a medicinal product
I	In all other cases, such devices are classified as class I	·         Non-invasive devices that provide a simple channelling function, with gravity providing the force to transport the liquid, e.g. administration sets for infusion ·         Devices intended to be used for a temporary containment or storage function_, e.g._ cups and spoons specifically intended for administering medicines2 Empty syringes without needles

Practical issues of classification

If a device, e.g. tubing, intended to be used for a purpose that would require it to be connected to an active device, such a device will be automatically in class IIa, unless the manufacturer clearly states that it should not be connected to an active device of class IIa or higher.

Note 1: ‘May be connected to an active device’ – such a connection is deemed to exist between a non-active device and an active device where the non-active device forms a link in the transfer of the substance between the patient and the active device and the safety and performance of one of the devices is influenced by the other device. For instance, this applies to tubing in an extracorporeal circulation system which is downstream from a blood pump and in the same blood flow circuit, but not directly connected to the pump.

Note 2: See also Chapter 3.1.6 regarding the possible measuring function.

Rule 3 Devices That Modify Biological Or Chemical Composition Of Human Tissues Or Cells, Blood, Other Body Liquids Or Other Liquids Intended For Implantation Or Administration Into The Body

General Explanation Of The Rule

These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They modify substances that will eventually be administered into the body. This rule covers mostly the more sophisticated elements of extracorporeal circulation sets, dialysis systems and autotransfusion systems as well as devices for extracorporeal treatment of body fluids which may or may not be immediately reintroduced into the body, including cases where the patient is not in a closed loop with the device.

This rule covers also substances in direct contact with human cells, tissues or organs in vitro before their implantation or administration, without substances derived from human or animal origin such as human albumin.

Class	Rule 3	Examples
IIb	All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb,	·         Devices intended to remove undesirable substances out of the blood by exchange of solutes such as hemodialy_s_ers ·         Devices intended to separate cells by physical means, e.g. gradient medium for sperm separation ·         Haemodialysis concentrates ·         Device removing specific blood cells (e.g. activated) by specific binding to a matrix
IIa	unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa	·         Particulate filtration of blood in an extracorporeal circulation system. These are used to remove particles from the blood ·         Centrifugation of blood to prepare it for transfusion or autotransfusion excluding centrifuges for manufacturing a medicinal product ·         Removal of carbon dioxide from the blood and/or adding oxygen ·         Warming or cooling the blood in an extracorporeal circulation system.
III	All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.	·         Substances or mixture of substances for transport, perfusion, storage of organs intended for transplantation that do not achieve the principal intended action by pharmacological, immunological or metabolic means ·       IVF or ART products without principal pharmacological/metabolic action (substances or mixture of substances) ·       IVF cell media without human albumin

Practical issues of classification

These devices are normally used in conjunction with an active medical device covered under Rule 9 or Rule 11.

Filtration and centrifugation should be understood in the context of this rule as being done exclusively through mechanical methods.

Rule 4 – Devices That Come Into Contact With Injured Skin Or Mucous Membrane

General Explanation Of The Rule

This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.

This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made, e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.

More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a lifesustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.

Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the human body fall under Rule 21.

Class	Rule 4	Examples
I	All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: – class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;	·         Wound dressings for skin or mucous, such as: absorbent pads, island dressings, cotton wool, wound strips, adhesive bandages (sticking plasters, band-aid) and gauze dressings which act as a barrier, maintain wound position or absorb exudates from the wound ·         Ostomy bags
IIb	– class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;	Are principally intended to be used with severe wounds: ·         Dressings intended for ulcerated wounds having breached the dermis ·         Dressings intended for burns having breached the dermis ·         Dressings for severe decubitus wounds ·         Dressings incorporating means of augmenting tissue and providing a temporary skin substitute
IIa	– class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and	·         Hydrogel dressings for wounds or injuries that have not breached the dermis or can only heal by secondary intent ·         Non-medicated impregnated gauze dressings Polymer film dressings
IIa	– class IIa in all other cases
!	This rule applies also to the invasive devices that come into contact with injured mucous membrane.	·         Dressings for nose bleeds (the purpose of the dressing is not to manage micro-environment) are in class I according to this rule ·         Dental wound dressings not containing animal derived material

Practical issues of classification

The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the wound healing process usually implies that the device is at least class IIa.

Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical barrier. Such devices are nevertheless classified according to their intended use in the higher class.

For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative, or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively.

Explanation Of Special Concepts

Breached dermis or mucosa: the wound exposes at least partly the subcutaneous tissue.

Secondary intent: the wound heals by first being filled with granulation tissue; subsequently the epithelium grows back over the granulation tissue and the wound contracts. In contrast, primary intent implies that the edges of the wound are close enough or pulled together, e.g. by suturing, to allow the wound to heal before formation of granulation tissue.

Invasive Devices

Rule 5 – Devices Invasive With Respect To Body Orifices

General Explanation Of The Rule

Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface (surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma, which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.

The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology, ophthalmology, dentistry, proctology, urology and gynaecology).

Class	Rule 5	Examples
I	All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as: class I if they are intended for transient use;	·         Handheld mirrors used in dentistry to aid in dental diagnosis and surgery ·         Dental impression materials ·         Stomach tubes ·         Impression trays ·         Examination gloves ·         Urinary catheters intended for transient use ·         Embryo transfer catheter and insemination catheter
IIa	– class IIa if they are intended for short-term use,	·         Short term corrective contact lenses ·         Tracheal tubes ·         Indwelling urinary catheters intended for short term use ·         Gasses used for insufflation in the body ·         Nasobilliary tubes
I	– except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and	·         Materials for dental impressions ·         Plastic syringe used to measure a quantity of medicinal product before oral administration to the patient ·         Removable or fixed dental prostheses
IIb	– class IIb if they are intended for long-term use.	·         Urethral stents ·         Long term corrective contact lenses ·         Tracheal cannulae for tracheostoma for long term use ·         Urinary catheters intended for long term use
IIa	– except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.	·         Orthodontic wires ·         Fixed dental prostheses ·         Fissure sealants
IIa	All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa	·         Tracheostomy or tracheal tubes connected to a ventilator ·         Blood oxygen analysers placed under the eye-lid ·         Powered nasal irrigators ·         Fibre optics in endoscopes connected to surgical lasers ·         Suction catheters or tubes for stomach drainage ·         Dental aspirator tips ·         Endoscopes using a light source in the visible spectrum

Practical issues of classification

Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For instance a trachea cannula for long-term use need to be classified as class IIb.

Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21

Rule 6 – Surgically Invasive Devices Intended For Transient Use (<60 Min)

General Explanation Of The Rule

This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae), surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.

Class	Rule 6	Examples
IIa	All surgically invasive1 devices intended for transient use are classified as class IIa unless they:	·         Needles used for suturing ·         Needles or syringes ·         Lancets ·         Single use scalpels and single use scalpel blades ·         Surgical swabs ·         Surgical gloves ·         Swabs to sample exudates ·         Guidewires or catheters used outside the central circulatory system
III	– are intended specifically to control, diagnose, monitor or correct a defect2 of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III3;	Cardiovascular catheters (e.g. angioplasty balloon catheters, stent delivery catheters/systems), including related guidewires, related introducers and dedicated3 disposable cardiovascular surgical instruments e.g. electrophysiological catheters, electrodes for electrophysiological diagnosis and ablation, ·         Catheters containing or incorporating sealed radioisotopes, where the radioactive isotope is not intended to be released into the body, if used in the central circulatory system ·         Distal protection devices
I	– are reusable surgical instruments, in which case they are classified as class I;	·         Scalpels and scalpel handles ·         Reamers ·         Drill bits ·         Saws, that are not intended for connection to an active device ·         Retractors forceps, excavators and chisels ·         Sternum retractors for transient use ·         Staplers (outside the heart, central circulatory or central nervous system ·         Dental Osteotomes
III	– are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;	·         Neuro-endoscopes ·         Brain spatulas ·         Direct stimulation cannulae ·         Spinal cord retractors ·         Spinal needles ·         Cranium guide for use in craniotomy ·         Dura mater protection; Bone punch for use on the cranium (Intended use: The dura mater protection is intended to protect the dura mater during surgical procedures. It has direct contact to the CNS. The bone punch can be used at the cranium. A direct contact to the CNS is possible during application.) ·         Peripherally inserted central catheter (PICC) line ·         Heart valve occluders, sizers and holders ·         Cardiovascular drainage cannula specifically intended to circulate blood whilst located in the heart or central vascular system ·         Cryo-ablation of the heart or spine ·         Appliers/Forceps for aneurysm clips
IIb	–  are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb; or	Catheters containing or incorporating sealed radioisotopes, where the radioactive isotope as such is not intended to be released into the body, excluding the central circulatory system
IIb	–  – have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb;	Viscoelastic solution for ophthalmic surgery
IIb	– are intended to administer medicinal products by means of a delivery system, if such –  administration of a medicinal product is done in a manner that is potentially hazardous4 taking account of the mode of application, in which case they are classified as class IIb.	·         Refillable insulin pens ·         Analgesia pumps

Practical Issues Of Classification/Explanation Of Special Concepts

Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable surgical instruments’.

Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to that of a scalpel.

Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect of the heart or of the central circulatory system.

Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user.

Rule 7 – Surgically Invasive Devices Intended For Short-Term Use (> 60 Min <30 Days)

General Explanation Of The Rule

These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles) and catheters of various types.

Class	Rule 7	Examples
IIa	All surgically invasive devices intended for short-term use are classified as class IIa unless they:	·         Clamps ·         Infusion cannulae ·         Skin closure devices ·         Temporary filling materials ·         Arthroscopy trocars ·         Insufflation    gases    for surgically       invasive endoscopic procedures
III	are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;	·         Cardiovascular catheters ·         Cardiac output probes ·         Temporary pacemaker leads ·         Thoracic catheters intended to drain the heart, including the pericardium ·         Carotid artery shunts ·         Ablation catheter ·         Heart bypass cannula (aortic perfusion cannula and venous drainage cannula) ·         Peripherally inserted central catheter (PICC) line and central line
III	are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;	·         Neurological catheters ·         Cortical electrodes ·         Central venous/vascular catheters
IIb	are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;	·         Brachytherapy devices
III	have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;	·         Absorbable sutures
IIb	are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or.	·         Vascular closure devices ·         Haemostatic foams
IIb	are intended to administer medicines, in which case they are classified as class IIb.	·         Temporal dialysis catheter, CVVH catheter

Practical issues of classification

Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive 2001/83/EC or Regulation (EC) No 726/2004.

Rule 8 – Implantable Devices And Long-Term Surgically Invasive Devices (> 30 Days)

General Explanation Of The Rule

These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used in plastic surgery.

Class	Rule 8	Examples
IIb	All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:	·         Artificial ligaments for reinforcement2. Dental implants and abutments ·         Shunts ·         Peripheral stents and peripheral valves ·         Plates ·         Intra-ocular lenses ·         Internal closure devices (including vascular closure devices1) ·         Tissue    augmentation    implants (excluding breasts) ·         Peripheral vascular catheters for long-term use ·         Peripheral vascular grafts and stents ·         Penile implants ·         Non-absorbable sutures, non-biodegreable bone cements and maxillo-facial implants, visco- elastic surgical devices intended specifically for ophthalmic anterior segment surgery2 ·         Pedicle screws
IIa	– are intended to be placed in the teeth3, in which case they are classified as class IIa;	·         Bridges and crowns ·         Dental filling materials and pins ·         Dental alloys, ceramics and polymers
III	– are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;	·         Prosthetic heart valves ·         Aneurysm clips ·         Vascular prosthesis and stents ·         Central vascular catheters for long-term use ·         Spinal stents ·         CNS electrodes ·         Cardiovascular sutures ·         Permanent and retrievable vena cava filters ·         Septal occlusion devices ·         Intra-aortic balloon pumps ·         External left ventricular assisting devices
III	– have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;	·         Long term absorbable sutures ·         Adhesives and implantable devices claimed to be bioactive through the attachment of surface coatings such as phosphoryl choline ·         Biodegrable Bone Cements ·         Elastoviscus fluids for joint movement(eg. hyaluronan of non-animal origin)
III	– are intended to undergo chemical change4 in the body in which case they are classified as class III, except if the devices are placed in the teeth
III	– are intended to administer medicinal products, in which case they are classified as class III;	·         Rechargeable non-active drug delivery systems Peritoneal dialysis
III	– are active implantable devices or their accessories, in which cases they are classified as class III;	·         Cochlear implants and accessories ·         Implantable cardiac pacemakers ·         Implantable cardioverter defibrillators (ICD) ·         Leads, electrodes, adaptors for pacemakers and implantable defibrillators ·         Implantable nerve stimulators ·         Implantable bladder stimulators ·         Implantable sphincter stimulators ·         Accessories to active implantable devices (with or without contact to the heart), be it implantable or non-implantable active or not5: ·         torque wrench for implantable pulse generator / implantable cardioverter defibrillator ·         cables for programmer / pacing system analyser ·         magnet for Implantable Pulse Generator / Implantable Cardioverter Generator ·         programmer or an external transmitter intended for activating or controlling the implantable part of the device ·         implantable pacemaker leads
III	– are breast implants or surgical meshes, in which cases they are classified as class III;	·         Breast implants ·         Breast tissue expanders ·         Surgical meshes for hernia repair ·         Tension free vaginal tape
III	– are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or	·         Hip, knee ·         Shoulder ·         Ankle
III	– are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments	·         Spinal disc replacement implants ·         Spinal implants: hooks that fix the rod on the spinal column ·         Stems that are implantable in contact with the spinal column ·         Device placed in the disc space ·         Interbody fusion devices

Practical issues of classification

Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).

Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the procedure. Rule 18 may also be relevant. Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb following the general rule.

Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes place during the placement and does not continue in long term.

Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8.

Active devices

Rule 9 – Active Therapeutic Devices Intended To Administer Or Exchange Energy, As Well As Active Devices Intended To Control/Monitor/Directly Influence Certain Devices

General Explanation Of The Rule

This rule covers many different groups of devices, such as:

• electrical equipment used in surgery such as lasers and surgical generators;
• stimulation devices;
• devices intended to emit ionizing radiation2for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance;
• devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
  Active implantable devices are covered by Rule 8.

Rule 22 may also apply to active therapeutic devices.

Class	Rule 9	Examples
IIa	All active therapeutic devices intended to administer or exchange energy are classified as class IIa	·         Electrical and/or magnetic and electromagnetic energy: ·         muscle stimulators ·         external bone growth stimulators ·         TENS devices ·         eye electromagnets ·         electrical acupuncture ·         Thermal energy: ·         heat exchangers, except the types described below ·         Mechanical energy: ·         powered dermatomes ·         powered drills ·         dental hand pieces ·         Light: ·         phototherapy for skin treatment and for neonatal care ·         Sound: ·         external hearing aids ·         Ultrasound: ·         equipment for physiotherapy ·         Sleep   apnoea   ventilators   without            monitoring function
IIb	unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.	·         Kinetic energy: ·         lung ventilators ·         Thermal energy: ·         incubators for babies ·         blood warmers ·         electrically powered heat exchangers (with patients incapable of reacting, communicating /or who are without a sense of feeling) ·         Electrical energy: ·         high-frequency electrosurgical generators, and electrocautery equipment, including their electrodes ·         external pacemakers and external defibrillators with no integrated or incorporated diagnostic function ·         electroconvulsive therapy equipment ·         Coherent light: ·         surgical lasers ·         Ultrasound: ·         lithotriptors, surgical ultrasound devices ·         high-intensity focused ultrasound (HIFU)
IIb	All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.	External feedback systems for active therapeutic devices
IIb	All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb	·         Brachytherapy therapy devices if the device also generates the radiation ·         Therapeutic cyclotrons and linear accelerators Therapeutic X-ray sources
III	All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III	·         Programming units and pacing system analysers ·         Cardioscopes with pacing pulse indicators specifically intended to monitor active implantable devices ·         Programmer for: ·         implantable Pulse Generator (IPG); ·         implantable Cardioverter Defibrillator (ICD) ·         implantable Loop Recorder ·         Remote monitoring devices for active implantable devices

Practical issues of classification

Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management (e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors should be in Class IIb. However, the manufacturer’s obligation to comply with design requirements and solutions adopted, exist independently from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.

Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).

Rule 10 – Active Devices For Diagnosis And Monitoring Or Intended For Diagnostic Or Therapeutic Radiology

General Explanation Of The Rule

This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active implantable devices fall under Rule 8 or Rule 9.

Class	Rule 10	Examples
IIa	Active devices intended for diagnosis and monitoring are classified as class IIa: – if they are intended to supply energy which will be absorbed by the human body,	·         Magnetic resonance equipment ·         Pulp testers ·         Evoked response stimulators ·         Diagnostic ultrasound
I	except for devices intended to illuminate1 the patient’s body, in the visible spectrum, in which case they are classified as class I;	·         Examination lamps ·         Surgical microscopes intended to illuminate the patient’s body in the visible spectrum ·         Dermatoscopes with integrated light sources
IIa	– if they are intended to image in vivo distribution of radiopharmaceuticals; or	·         Gamma cameras ·         Positron emission tomography and single photon emission computer tomography
IIa	– if they are intended to allow direct diagnosis2 or monitoring of vital physiological processes3,	·         Electrocardiographs ·         Electroencephalographs ·         Electronic thermometers ·         Electronic stethoscopes ·         Electronic blood pressure measuring equipment
IIb	unless they are specifically intended for monitoring of vital physiological parameters3 and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.	·         Blood gas analysers used in open heart surgery ·         Apnoea monitors, including apnoea monitors in home care ·         Patient monitors (intended use: Monitor intended for multi-parameter patient monitoring. The device will produce visual and audible alarms if any of the physiological parameters monitored vary beyond pre-set limits and timed alarm recordings will be produced.), for example in intensive care monitoring, e.g. blood pressure, temperature, oxygen saturation
IIb	Active devices intended to emit ionizing radiation4 and intended for diagnostic or therapeutic radiology5, including interventional radiology devices5 and devices which control or monitor6 such devices, or which directly influence their performance, are classified as class IIb.	·         Diagnostic X-Ray machine ·         Computed Tomography Devices

Practical Issues Of Classification / Explanation Of Special Concepts

Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.

Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance document covering the borderline between medical devices and medicinal products.

Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia, intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a body temperature measuring device.

Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).

Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure. Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.

Rule 11 – Software Intended To Provide Information To Inform Decisions With Diagnosis Or Therapeutic Purposes Or Software Intended To Monitor Physiological Processes.

General Explanation Of The Rule

Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software to the healthcare decision and the healthcare situation or patient’s condition.

This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the subrule only applies to software intended for monitoring purposes only).

Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an accessory.

Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices
(see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses etc.

Class	Rule 11	Examples
IIa	Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:	·         MDSW intended to rank therapeutic suggestions for a health care professional based on patient history, imaging test results, and patient characteristics, for example, MDSW that lists and ranks all available chemotherapy options for BRCA-positive individuals. ·         Cognitive therapy MDSW where a specialist determines the necessary cognitive therapy based on the outcome provided by the MDSW.
III	— death or an irreversible deterioration of a person’s state of health1, in which case it is in class III; or	·         MDSW intended to perform diagnosis by means of image analysis for making treatment decisions in patients with acute stroke.
IIb	— a serious deterioration of a person’s state of health1 or a surgical intervention, in which case it is classified as class IIb.	·         A mobile app intended to analyse a user’s heartbeat, detect abnormalities and inform a physician accordingly. MDSW intended for diagnosing depression based on a score resulting from inputted data on patient symptoms (e.g. anxiety, sleep patterns, stress etc.).
IIa	Software intended to monitor physiological processes is classified as class IIa,	·         MDSW intended to monitor physiological processes that are not considered to be vital. ·         Devices intended to be used to obtain readings of vital physiological signals in routine check-ups including monitoring at home.
IIb	except if it is intended for monitoring of vital physiological parameters3, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.	·         Medical devices including MDSW intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.
I	All other software is classified as class I.	·         MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. The user inputs health data including basal body temperature ·         (BBT) and menstruation days to track and predict ovulation. The fertility status of the current day is reflected by one of three indicator lights: red (fertile), green (infertile) or yellow (learning phase/cycle fluctuation).

**Practical Issues Of Classification

Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at:
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .

Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by the software as well as of the possible decisions to be taken.

Note 3 Medical device software should be classified in the same way, regardless of the software’s location or the type of interconnection between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a device or influences the use of a device shall fall within the same class as the device.

For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software –
Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Rule 12 – Active Devices Intended To Administer And/Or Remove Medicinal Products, Body Liquids Or Other Substances To Or From The Body

General Explanation Of The Rule

This rule is intended to primarily cover drug delivery systems and anaesthesia equipment. If the device’s intended route of drug delivery is pulmonary, Rule 20 applies.

Class	Rule 12	Examples
IIa	All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa,	·         Suction pump ·         Feeding pumps ·         Jet injectors for vaccination ·         Elastomeric pumps or balloon pumps for infusion
IIb	unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.	·         Infusion pumps ·         Ventilators ·         Anaesthesia machines ·         Anaesthetic vaporisers ·         Dialysis equipment ·         Blood pumps for heart-lung machines ·         Hyperbaric chambers ·         Pressure regulators for medical gases ·         Medical gas mixers ·         Moisture exchangers in breathing circuits if used on unconscious or non-spontaneously breathing patients ·         Oxygen concentrator used to deliver oxygen enriched air directly to the patient

Rule 13 – All Other Active Devices

General Explanation Of The Rule

This is a fallback rule to cover all active devices not covered by other rules.

Class	Rule 13	Examples
I	All other active devices are classified as class I.	·         Electric wheelchairs ·         Dental curing lights ·         Electric hospital beds ·         Patient hoists ·         Dental patient chairs

Special rules

Rule 14 – Devices Incorporating, As An Integral Part, An Ancillary Medicinal Product, And Medicinal Products Derived From Human Blood Or Blood Plasma

General Explanation Of The Rule

This rule covers those devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, with an action ancillary to that of the device. The principal intended action of the device must not be achieved through a pharmacological, immunological or metabolic action of the incorporated medicinal substance1. If the principal intended action of the device is mainly achieved by the action of the medicinal substance, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council, as applicable. For more information see the MDCG Guidance document covering the borderline between medical devices and medicinal products. The same principle applies if a substance of animal origin, as defined in Art. 2(17), is part of the device and has an action ancillary to that of a device.

Class	Rule 14	examples
III	All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.	·         Bone cement with antibiotics ·         Condoms with spermicide ·         Catheters coated with anticoagulants (e. g. heparin) ·         Endodontic materials with antibiotics ·         Ophthalmic irrigation solutions principally intended for irrigation, which contain components supporting the metabolism of the endothelial cells of the cornea ·         Dressings incorporating an antimicrobial agent where the agent has an ancillary action on the wound ·         Drug eluting stents (e.g. coronary, pulmonary) ·         Surgical sealants containing human serum albumin or thrombin ·         Implants coated with human fibrinogen ·         Blood bags incorporating heparin or other substances as anticoagulant agents which, if used separately, can be considered to be a medicinal product ·         IVF cell media with human albumin2 ·         Intra Uterine Devices (IUD) containing medicinal substances3 including copper or silver ·         Catheter lubrication gels containing analgesia, e.g. lidocaine

**Practical Issues Of Classification

Note 1: The definition of ‘substance’ in Article 1 (3) of Directive 2001/83/EC is applicable as far as not excluded by the MDR (e. g. exclusion criteria Article 1 (6) (h)).

Note 2: IVF cell media with human albumin are in class III according to Rule 14 and Rule 3. (Rule 14 applies, being the strictest, according to MDR, Annex VIII, chapter II, point 3.5.)
Note 3: This only applies if the effect of the medicinal substance is ancillary – if it is the main effect, the IUD would be classified as a medicinal product N.B.: For the clarification of the meaning and application of ‘a substance which, if used separately, can be considered to be a medicinal product’ and of ‘has an action ancillary to that of the device’, clarification which is relevant for the application of this rule, see clarification provided in the respective section of the MDCG Guidance document covering the borderline between medical devices and medicinal products.

Rule 15 – Devices Used For Contraception Or Prevention Of Sexually Transmitted Diseases

General Explanation Of The Rule

This rule covers invasive, implantable and non-invasive medical devices for contraception or prevention of sexually transmitted diseases, i.e.
this rule is not limited to devices based on physical barriers. The rule covers contraception devices and devices used in prevention of transmission of sexually transmitted diseases, where non-invasive, devices for transient or short term use are of class IIb and long-term use or implantable devices are of class III.

Devices for fertility monitoring or testing to facilitate conception (and not used in contraception) are not covered by this rule. Some devices may have dual functions, intended to be used both for contraception and prevention of the transmission of sexually transmitted diseases, e.g. condoms.

Class	Rule 15	Examples
IIb	All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb,	·         Condoms and femidoms (internal condoms) ·         Contraceptive diaphragms ·         Fertility monitors and medical device software intended to be used in contraception (e.g. by using the basal body temperature)
III	unless they are implantable or long term invasive devices, in which case they are classified as class III.	·         Tubal ligation devices (e.g. clips or rings) ·         Non-hormonal      intrauterine contraceptive devices (IUCD or ICD)

Rule 16 – Specifically Disinfecting, Cleaning, Rinsing, Hydrating Or Sterilising Devices

General Explanation Of The Rule

This rule is intended to cover various products used specifically with contact lenses such as solutions intended for storing contact lenses and solutions used to support contact lenses placed on the ocular surface. The rule also covers substances and equipment specifically intended for the disinfection or sterilisation of devices intended by the manufacturer to be sterilised or disinfected prior to use, as referred to in MDR Article 2(1).

This rule does not apply to physical means for the cleaning of medical devices, such as ultrasound and brushes for general use. Such products will only be medical devices if they are specifically intended for the cleaning, disinfection or sterilisation of medical devices. Devices specifically intended for physical cleaning of contact lenses are covered by this rule.

Class	Rule 16	Examples
IIb	All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.	·         Contact lens storing solutions ·         Cleaners for contact lenses ·         Ultraviolet, vibration, or ultrasonic devices for cleaning and disinfecting contact lenses
IIa	All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa,	·         Disinfecting solutions specifically intended for non-invasive medical devices ·         Washer-disinfectors   intended specifically                 for disinfecting non-invasive medical devices ·         Sterilisers intended to sterilise medical devices in a medical environment
IIb	unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing1, in which case they are classified as class IIb.	·         Solutions/disinfectors for trans oesophageal ultrasound probes) ·         Washer-disinfector equipment specifically for disinfecting endoscopes or other invasive devices at the end point of processing (e. g. dental equipment) ·         Disinfectants for the fluid pathways of haemodialysis equipment ·         Denture disinfecting products
!	This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.	·         Brushes specifically intended to clean medical devices by mechanical action ·         Ultrasonic devices (for other devices than contact lenses)

Practical Issues Of Classification

Note 1: Including disinfecting solutions or washer-disinfectors that require no further processing for a disinfected device ready to be used. The rule also covers devices where the intended use is to disinfect prion contaminations.

Rule 17 – Devices To Record X-Ray Diagnostic Images

General Explanation Of The Rule

This rule covers stand-alone X-ray detectors and sensors as recording devices used in several types or modalities of medical imaging procedures, each of which uses different technologies and techniques. It covers non-active devices and active devices used to record X-ray diagnostic images of the human body. The intention of the rule is to cover primarily digital devices and analogous recording media, but not media (including digital media) used for subsequent image processing and storage.

Class	Rule 17	Examples
IIa	Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.	·         Digital x-ray detectors for recording images ·         Photostimulable phosphor plates ·         X-ray films

Practical Issues Of Classification

Note 1: Devices intended to emit ionizing radiation for diagnostic and or therapeutic purposes are not covered by this rule. See Rule 10.

Rule 18 – Devices Manufactured Utilizing Tissue Or Cells Of Human Or Animal Origin Or Their Derivatives

General Explanation Of The Rule

This rule covers devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, i.e. where there is no longer any capacity for cellular metabolic activity. This includes devices containing derivatives of human origin that have an ancillary action to that of the device, as well as devices that contain or are made of animal tissues (non-derivative) that have been rendered non-viable, or their derivatives.

Class	Rule 18	Examples
III	All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives1, which are non- viable or rendered non-viable, are classified as class III,	·         Animal derived biological heart valves ·         Porcine xenograft dressings ·         Devices     made      from animal       sourced collagen/gelatine ·         Devices utilising hyaluronic acid of animal origin ·         Substance-based devices containing collagen for use in body orifices ·         Collagen dermal fillers ·         Bone graft substitutes
I	unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.	·         Leather components of orthopaedic appliances

Practical Issues Of Classification

Note 1: Derivatives are products that are processed from animal tissues and excludes products made by animals e.g. milk, silk, beeswax, honey, propolis, royal jelly, hair, lanolin.

Note 2: The industrial manufacturing process for some devices may employ raw materials which contain small amounts of tallow or tallow derivatives (e.g. stearates in polymers) for example for greasing the moulds. Such substances, which may be present in the final device only as trace amounts, are not considered as derivatives of animal tissues for the purpose of this rule which therefore does not apply. However, if such substances are a constituent part of a device the rule will apply, for example wound dressings impregnated with tallow. Such an exemption applies only to classification, and not to other obligations related to devices manufactured utilising non-viable substances of animal origin, such as those referred to in Annex I 13.2.

Note 3: This rule does not apply to devices manufactured utilizing tissues or cells of animal origin or their derivatives coming into contact with intact skin only. In such cases they are in class I in accordance to Rule 1. Intact skin includes the skin around an established stoma unless the skin is breached.

Rule 19 – Devices Incorporating Or Consisting Of Nanomaterial

General Explanation Of The Rule

The concept of internal exposure is a key element for the classification incorporating or consisting of nanomaterials. In its ‘Opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’30, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) states as a conclusion, that the potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure. Table 3 of the SCENIHR Opinion estimates both external and internal exposure based on the type of device, type of application, type (location) of contact, and duration of contact. As indicated in the explanation of table 3 of the SCENIHR opinion, the ‘potential internal systemic exposure of all organ systems’ is what is listed, which can be expected to occur after release of free nanoparticles from invasive devices as well as from non-invasive devices in contact with a breached or compromised body surface. This Table 3 uses the terms high/medium/low/negligible, as also used in the classification rule. This Table 3 could be used as a starting point for correct classification. This Table 3 indicates a value for potential contact and/or external exposure to the nanomaterial and potential internal systemic exposure of all organ systems However, every individual device needs to be classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account the exposure by the same nanomaterial via daily exposure routes., Also factors such as the number of nanomaterials in or on the product and the amount of product applied in the intended use have been taken into account. This Table 3 indicates a value for potential contact and/or external exposure to the nanomaterial and potential internal systemic exposure of all organ systems.

Class	Rule19	Examples
	All devices incorporating or consisting of nanomaterial are classified as
III	—class III if they present a high1 or medium potential for internal exposure2	·         Bone fillers with nanomaterials in their formulation (not polymerized before blood/tissue contact, and degradable) ·         Superparamagnetic           iron           oxide                                         nanoparticles (Intended use: thermal ablation of tumors or thermal modulation of the tumor microenvironment by submission to alternating magnetic fields) ·         Intravascular catheter made of non-degradable polymer, with nano-coating31
IIb	— class IIb if they present a low1 potential for internal exposure	·         Bone fixation screws/plates with a strongly bound nano-coating high potential ·         Solution administration set made of non-degradable polymer, with a strongly bound nano-coating
IIa	— class IIa if they present a negligible1 potential for internal exposure	·         Intravascular catheter for short term use made of non- degradable polymer, with nanomaterial embedded in the polymer matrix ·         Solution administration set made of non-degradable polymer, with nanomaterial embedded in the polymer matrix ·         Dental filling materials

Practical Issues Of Classification

Note 1: The high, medium, low or negligible potential of internal exposure is based on the combination of different factors such as the application site of a medical device, type of contact (e.g. tissue, cells or body fluids), contact time and the type of incorporation of the nanomaterial(s)
(free, fixed, embedded). When the nanomaterial is applied as coating on the surface of the device, it is important to consider the type of interaction with the material (chemisorption versus physisorption). When the nanomaterial is embedded in a matrix it will be important to consider the degradability of the material.

Note 2: Internal exposure: exposure may occur via injured skin or mucous membrane, (surgically) invasive devices and implantable devices.

Note 3: Dental materials which are placed in the patient’s teeth in a paste form, where they are cured to a solid form, may release nanomaterials during a very short exposure time. For most of the exposure time, these devices contain firmly bound nanomaterials. In many cases, grinding and/or polishing takes place during the application of the device, and could also lead to exposure to nanomaterials. Such nanomaterials do not necessarily contain the original nanomaterials present in the paste formulation. It is very important to include this aspect in the risk assessment of such devices. For classification purposes the potential internal exposure to nanomaterials from these devices can generally be considered negligible. Classification of this kind of materials should be based on the first state, in this example, the short exposure to the paste form which has higher potential for release than the cured material.

Note 4: Devices with components incorporating nanomaterials that have no intended direct or indirect contact with users or patients, such as the tires of wheelchairs or walking frames made from rubber reinforced with carbon black nanomaterials, should be exempt from classification under Rule 19.

Note 5: Medical devices not incorporating or consisting of nanomaterials can still present a potential for internal exposure to nanomaterials due to degradation or wear processes. While it is very important to include this aspect in the risk assessment of such devices, it is not a factor to be considered when deciding the classification under Rule 19 since this rule is only applicable for medical devices incorporating or consisting of nanomaterials.

Rule 20 – Invasive Devices, Intended To Administer Medicinal Product By Inhalation

General Explanation Of The Rule

This rule covers active and non-active medical devices with a respiratory route of drug delivery.

In contrast to other rules covering devices that administer medicinal products, Rule 20 is also specifically intended to cover medical devices where the impact of the medical device on the efficacy and safety of the administered medicinal product is critical. The rule also covers drugdelivery products that are intended to treat life-threatening conditions.

Class	Rule 20	Examples
IIa	All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa,	·         Spacer intended for metered dose inhalers (attached to the inhaler) unless treating life- threatening conditions. ·         Inhalers for nicotine replacement therapy (nicotine not included) ·         Oxygen delivery system with a nasal cannula unless treating life-threatening conditions ·         Inhalers and nebulisers in case their mode of action has probably no essential impact on the efficacy and safety of the administered medicinal product or which are not intended to treat life-threatening conditions
IIb	unless their mode of action has an essential impact1 on the efficacy and safety of the administered medicinal product or they are intended to treat life- threatening conditions, in which case they are classified as class IIb	·         Nebulisers (not pre-charged with a specific medicinal product) where the failure to deliver the appropriate dosage characteristics could be hazardous ·         Spacer intended for metered dose inhalers attached to the inhaler.

Practical Issues Of Classification

Note 1. ‘Essential impact’ includes drug delivery systems where the device has a significant impact on factors that influence inhaled medicinal product deposition within the airways including inhalation flow, aerosol velocity, the particle size of the inhaled drug and the amount of drug reaching the patient.

Rule 21 Devices Composed Of Substances That Are Introduced Via A Body Orifice Or Applied To The Skin

General Explanation Of The Rule

This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are not excluded by the MDR (e.g. exclusion criteria in article 1 (6) (h)). The specific medical purpose is specified by the manufacturer from those listed in the indents of Article 2(1) MDR.

Importantly, if the principal intended action of such substance-based medical devices is achieved or supported by pharmacological, immunological or metabolic means, Directive 2001/83/EC or Regulation (EC) No 726/2004 or Rule 14 has to be applied to the product, respectively.

The classification takes into account the site of application of the medical device as well as the site where the medical device performs its action in or on the human body. For the purpose of this rule nails are also considered as falling under ‘skin’.

Manufacturers of substance-based devices should provide clear information supporting the mode of action through which the substance achieves the intended specific medical purpose as a basis for the application of this rule, including the site of application as well as the site where the action is achieved in or on the body.

Class	Rule 21	Examples
III	Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as: — class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;
III	— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;	·         Na/Mg alginate, xyloglucan ·         Fat    absorbers   that    are         systemically absorbed, themselves or their metabolites
IIa	— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx1, and achieve their intended purpose on those cavities; and	·         Substance-based formulations for skin treatment ·         Salt water used e.g. as nose or throat sprays ·         Oral cough treatments achieving their intended purpose in the oral cavity as far as the pharynx
IIb	— class IIb in all other cases.	·         Simethicone     preparations                        for                        oral administration ·         Active coal for oral administration ·         Gel for vaginal moisturizing / vaginal lubricants ·         Eye drops for hydration ·         Ear drops1, 2 ·         Medical devices, for oral administration, for the treatment of diarrhoea, e.g. kaolin, diosmectite ·         Medical devices, for oral administration, for the treatment of obesity, e.g. fructooligosaccharides, glucomannan

Practical Issues Of Classification

Products acting in the nasal or oral cavity may be to some extent be ingested or inhaled. These products will be class IIa devices if the products achieve their intended purpose solely in these cavities, and not in the respiratory tract, stomach or lower gastrointestinal tract.

N.B.: examples provided do not imply that the products are a priori qualified as devices. Classification rules apply after the qualification of the device has been established.

Note 1: There is a normal anatomical connection, the Eustachian tube, from the middle ear to the nasopharynx. If the Eustachian tube was to be accessed from the nasopharynx direction, this would be considered beyond the pharynx, so this does not fulfil the criteria of ‘as far as the pharynx’.

Note 2: In the majority of cases the drops would only enter the ear as far as the ear drum. This is regarded as applied to the skin. The outer layer of the tympanic membrane is epithelium, so if there is an intact tympanic membrane, then the drops are applied only to the skin and has its action locally, and consequently the device would be class IIa. This will be the case unless the ear drum (tympanic membrane) is perforated and the product is intended to be used on perforated ear drums.

Rule 22 Active Therapeutic Devices, With An Incorporated Diagnostic Function

General Explanation Of The Rule

This rule is intended for therapeutic devices whose intended functionality is dependent to a significant degree on an integrated or incorporated diagnostic function.

Automated or ‘closed-loop’ therapeutic systems are systems in which relevant biological conditions are automatically monitored (uses feedback from physiological sensors) and is used to adjust a therapy in order to maintain or achieve a particular physiological state. Such devices are normally used in precision medicine and/or personalised therapies for obtaining optimal therapeutic efficacy. This rule covers systems such as autonomic pharmacological (drug-delivery) and neuromodulation systems.

Class	Rule 22	Examples
III	Active therapeutic devices with an integrated or incorporated diagnostic function1 which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.	·         Automated     external defibrillators   (AED) including their pads/electrodes ·         Semiautomatic external defibrillators ·         Automated closed loop insulin delivery system ·         Automated external infusion pumps with integrated sensors to adapt the infusion therapy ·         Devices in brain-computer interfaces (BCIs) – used for e.g. motor control in severely paralyzed patients ·         Closed-loop systems for deep brain stimulation (DBS) treatment of various neurological conditions ·         Closed-loop dynamic neurochemical control of therapeutic interventions e.g. target-controlled anaesthesia / infusion systems

Practical Issues Of Classification

Note 1. ‘Integrated or incorporated diagnostic function’ means the functionality of a system including a physiological sensors e.g. the AED electrodes/pads using a feedback control to process and record changes in the patient’s physiological state to continuously adjust a therapy. The diagnostic function can be physically integrated or a component of an external sub-system.

注意：

1. 目录中的申报资料名称后标记为“CR”的，需要根据产品类型、注册申报情形等判断是否适用，如不适用则该资料无需提交。
2. 高亮显示的文档为进口产品注册时需要公证的资料（关联文件、符合性声明以及说明书、标签应当提交由注册申请人所在地公证机构出具的公证件)

第1章 监管信息

• CH1.2 章节目录
• CH1.3 术语、缩写词列表 CR
• CH1.4 申请表
• CH1.5 产品列表
• CH1.6 质量管理体系、全面质量体系或其他证明文件
• CH1.7 自由销售证书/上市证明文件 CR
• CH1.9 申报前联系情况和与监管机构的既往沟通记录
• CH1.11.1 标准清单及符合性声明
• CH1.11.3 临床试验审批相关文件 CR
• CH1.11.5 真实性和准确性声明
• CH1.11.7 符合性声明
• CH1.12 主文档授权信 CR
• CH1.13 代理人委托书
• CH1.14 其他监管信息 CR

第2章 综述资料

• CH2.1 章节目录
• CH2.2 申报综述
• CH2.4.1 全面的器械组成、功能及作用原理等内容描述
• CH2.4.2 器械包装描述
• CH2.4.3 器械研发历程
• CH2.4.4 与相似和/或前几代器械的参考和比较（国内外已上市）
• CH2.5.1 预期用途；使用目的；预期使用者；适用范围
• CH2.5.2 预期使用环境/安装要求
• CH2.5.3 儿童使用相关说明 CR
• CH2.5.4 使用禁忌证
• CH2.6.1 全球上市情况
• CH2.6.2 全球不良事件和召回情况
• CH2.6.3 全球销售、不良事件情况及召回率
• CH2.7 其他申报综述信息

第3章 非临床资料

• CH3.1 章节目录
• CH3.2 风险管理
• CH3.3 医疗器械安全和性能基本原则（EP）清单
• CH3.4.1 标准列表
• CH3.4.2 符合性声明和/或认证（产品技术要求 / 产品检验报告）
• CH3.5 非临床研究（根据产品性质、设计、功能等来确定适用的非临床研究项目）
  • CH3.5.1 物理和机械性能
  • CH3.5.2 化学/材料表征
  • CH3.5.3 电气系统：安全、机械和环境保护以及电磁兼容性
  • CH3.5.4 辐射安全
  • CH3.5.5 独立软件/软件组件 （SaMD， SiMD， AI/ML-based SW， Mobile APP， Cloud Computing， VR…）, 网络安全（CH3.5.5.11），互操作性（CH3.5.5.12）
  • CH3.5.6 生物相容性和毒理学评价
  • CH3.5.7 非材料介导的热原
  • CH3.5.8 生物来源（人类/动物）材料的安全性
  • CH3.5.9 灭菌确认
  • CH3.5.10 动物试验
  • CH3.5.11 可用性/人为因素
• CH3.6 非临床研究文献
• CH3.7.1 产品稳定性 CR
• CH3.7.2 包装验证
• CH3.8 其他资料

第4章 临床评价资料

• CH4.1 章节目录
• CH4.2 临床支持性文件综述 CR
• CH4.2.1 临床评价资料 CR
• CH4.2.2 临床试验资料 CR
• CH4.2.3 临床文献综述及其他相关资料 CR
• CH4.3 伦理委员会批准的相关文件 CR
• CH4.5 其他临床证据 CR

第5章 产品说明书和标签样稿

• CH5.1 章节目录
• CH5.2 产品/包装标签
• CH5.3 使用说明书
• CH5.5 医生使用说明书 CR
• CH5.6 患者使用说明书 CR
• CH5.7 技术人员/操作人员使用手册 CR
• CH5.10 其他说明书标签材料 CR

第6A章 质量管理体系文件

• CH6A.1 申请综述函
• CH6A.2 章节目录
• CH6A.3.1 产品描述信息
• CH6A.3.2 一般生产信息
• CH6A.4 质量管理体系程序
• CH6A.5 管理责任程序
• CH6A.6 资源管理程序
• CH6A.7 产品实现程序（设计和开发程序、采购程序、生产和服务控制程序、监视和测量装置控制程序） CR
• CH6A.8 测量、分析和改进程序
• CH6A.9 其他质量体系程序 CR

第6B章 申报器械的质量管理体系信息

• CH6B.1 章节目录
• CH6B.2 质量管理体系信息

注意：

1. 目录中的申报资料名称后标记为“CR”的，需要根据产品类型、注册申报情形等判断是否适用，如不适用则该资料无需提交。
2. 高亮显示的文档为进口产品注册时需要公证的资料（关联文件、符合性声明以及说明书、标签应当提交由注册申请人所在地公证机构出具的公证件)

第1章 监管信息

• CH1.2 章节目录
• CH1.4 申请表
• CH1.6 质量管理体系、全面质量体系或其他证明文件 CR
• CH1.7 自由销售证书/上市证明文件 CR
• CH1.9 申报前联系情况和与监管机构的既往沟通记录
• CH1.11.1 标准清单及符合性声明
• CH1.11.5 真实性和准确性声明
• CH1.11.7 符合性声明
• CH1.12 主文档授权信 CR
• CH1.13 代理人委托书
• CH1.14 其他监管信息

第2章 综述资料

• CH2.1 章节目录
• CH2.2 申报综述
• CH2.4.1 全面的器械组成、功能及作用原理等内容描述
• CH2.4.2 器械包装描述 CR
• CH2.4.3 器械研发历程 CR
• CH2.4.4 与相似和/或前几代器械的参考和比较（国内外已上市）CR
• CH2.5.1 预期用途；使用目的；预期使用者；适用范围 CR
• CH2.5.2 预期使用环境/安装要求 CR
• CH2.5.3 儿童使用相关说明 CR
• CH2.5.4 使用禁忌证 CR
• CH2.6.1 全球上市情况 CR
• CH2.6.2 全球不良事件和召回情况 CR
• CH2.6.3 全球销售、不良事件情况及召回率 CR
• CH2.7 其他申报综述信息 CR

第3章 非临床资料

• CH3.1 章节目录
• CH3.2 风险管理
• CH3.4.1 标准列表 CR
• CH3.4.2 符合性声明和/或认证（产品技术要求 / 产品检验报告）CR
• CH3.5 非临床研究 （根据产品性质、设计、功能等来确定适用的非临床研究项目）CR
  • CH3.5.1 物理和机械性能
  • CH3.5.2 化学/材料表征
  • CH3.5.3 电气系统：安全、机械和环境保护以及电磁兼容性
  • CH3.5.4 辐射安全
  • CH3.5.5 独立软件/软件组件 （SaMD，SiMD，AI/ML-based SW， Mobile APP，Cloud Computing，VR…）, 网络安全（CH3.5.5.11），互操作性（CH3.5.5.12）
  • CH3.5.6 生物相容性和毒理学评价
  • CH3.5.7 非材料介导的热原
  • CH3.5.8 生物来源（人类/动物）材料的安全性
  • CH3.5.9 灭菌确认
  • CH3.5.10 动物试验
  • CH3.5.11 可用性/人为因素
• CH3.6 非临床研究文献 CR
• CH3.7.1 产品稳定性 CR
• CH3.7.2 包装验证 CR
• CH3.8 其他资料 CR

第4章 临床评价资料

• CH4.1 章节目录 CR
• CH4.2 临床支持性文件综述 CR
• CH4.2.1 临床评价资料 CR
• CH4.2.2 临床试验资料 CR
• CH4.2.3 临床文献综述及其他相关资料 CR
• CH4.3 伦理委员会批准的相关文件 CR
• CH4.5 其他临床证据 CR

第5章 产品说明书和标签样稿

• CH5.1 章节目录
• CH5.3 使用说明书
• CH5.5 医生使用说明书 CR
• CH5.6 患者使用说明书 CR
• CH5.7 技术人员/操作人员使用手册 CR
• CH5.10 其他说明书标签材料 CR

第6A章 质量管理体系文件

• CH6A.1 申请综述函
• CH6A.2 章节目录
• CH6A.3.1 产品描述信息 CR
• CH6A.3.2 一般生产信息 CR
• CH6A.4 质量管理体系程序 CR
• CH6A.5 管理责任程序 CR
• CH6A.6 资源管理程序 CR
• CH6A.7 产品实现程序（设计和开发程序、采购程序、生产和服务控制程序、监视和测量装置控制程序） CR
• CH6A.8 测量、分析和改进程序 CR
• CH6A.9 其他质量体系程序 CR

第6B章 申报器械的质量管理体系信息

• CH6B.1 章节目录
• CH6B.2 质量管理体系信息

注意：

1. 目录中的申报资料名称后标记为“CR”的，需要根据产品类型、注册申报情形等判断是否适用，如不适用则该资料无需提交。
2. 高亮显示的文档为进口产品注册时需要公证的资料（关联文件、符合性声明以及说明书、标签应当提交由注册申请人所在地公证机构出具的公证件)
3. 《医疗器械注册与备案管理办法》第79条：注册人名称和住所、代理人名称和住所等，属于前款规定的需要备案的事项。
4. 不收费

第1章 监管信息

• CH1.2 章节目录
• CH1.4 申请表
• CH1.6 质量管理体系、全面质量体系或其他证明文件 CR
• CH1.7 自由销售证书/上市证明文件 CR
• CH1.9 申报前联系情况和与监管机构的既往沟通记录 CR
• CH1.11.1 标准清单及符合性声明
• CH1.11.5 真实性和准确性声明
• CH1.11.7 符合性声明
• CH1.13 代理人委托书
• CH1.14 其他监管信息

第2章 综述资料

• CH2.1 章节目录 CR
• CH2.2 申报综述
• CH2.4.1 全面的器械组成、功能及作用原理等内容描述

注意：

1. 目录中的申报资料名称后标记为“CR”的，需要根据产品类型、注册申报情形等判断是否适用，如不适用则该资料无需提交。
2. 高亮显示的文档为进口产品注册时需要公证的资料（关联文件、符合性声明以及说明书、标签应当提交由注册申请人所在地公证机构出具的公证件)

第1章 监管信息

• CH1.2 章节目录
• CH1.3 术语、缩写词列表 CR
• CH1.4 申请表
• CH1.6 质量管理体系、全面质量体系或其他证明文件
• CH1.9 申报前联系情况和与监管机构的既往沟通记录
• CH1.11.1 标准清单及符合性声明
• CH1.11.5 真实性和准确性声明
• CH1.11.7 符合性声明
• CH1.13 代理人委托书
• CH1.14 其他监管信息

第3章 非临床资料

• CH3.1 章节目录 CR
• CH3.4.2 符合性声明和/或认证（产品技术要求）CR
• CH3.8 其他资料（注册证中载明要求继续完成的非临床研究事项） CR

第4章 临床评价资料

• CH4.1 章节目录 CR
• CH4.2.1 临床评价资料 CR
• CH4.5 其他临床证据 CR

注意：

1. 目录中的申报资料名称后标记为“CR”的，需要根据产品类型、注册申报情形等判断是否适用，如不适用则该资料无需提交。
2. 高亮显示的文档为进口产品注册时需要公证的资料（关联文件、符合性声明以及说明书、标签应当提交由注册申请人所在地公证机构出具的公证件)

第1章 监管信息

• CH1.2 章节目录
• CH1.3 术语、缩写词列表 CR
• CH1.4 申请表
• CH1.5 产品列表
• CH1.6 质量管理体系、全面质量体系或其他证明文件
• CH1.7 自由销售证书/上市证明文件 CR
• CH1.9 申报前联系情况和与监管机构的既往沟通记录
• CH1.11.1 标准清单及符合性声明
• CH1.11.5 真实性和准确性声明
• CH1.11.7 符合性声明
• CH1.13 代理人委托书
• CH1.14 其他监管信息 CR

第2章 综述资料

• CH2.1 章节目录
• CH2.4.1 全面的器械组成、功能及作用原理等内容描述
• CH2.4.4 与相似和/或前几代器械的参考和比较（国内外已上市）
• CH2.5.1 预期用途；使用目的；预期使用者；适用范围 CR
• CH2.5.2 预期使用环境/安装要求 CR
• CH2.5.3 儿童使用相关说明 CR
• CH2.5.4 使用禁忌证 CR
• CH2.7 其他申报综述信息 CR

第3章 非临床资料

• CH3.1 章节目录
• CH3.2 风险管理
• CH3.4.1 标准列表
• CH3.4.2 符合性声明和/或认证（产品技术要求 / 产品检验报告）
• CH3.5 非临床研究（根据产品性质、设计、功能等来确定适用的非临床研究项目）CR
  • CH3.5.1 物理和机械性能
  • CH3.5.2 化学/材料表征
  • CH3.5.3 电气系统：安全、机械和环境保护以及电磁兼容性
  • CH3.5.4 辐射安全
  • CH3.5.5 独立软件/软件组件 （SaMD， SiMD， AI/ML-based SW， Mobile APP， Cloud Computing， VR…）, 网络安全（CH3.5.5.11），互操作性（CH3.5.5.12）
  • CH3.5.6 生物相容性和毒理学评价
  • CH3.5.7 非材料介导的热原
  • CH3.5.8 生物来源（人类/动物）材料的安全性
  • CH3.5.9 灭菌确认
  • CH3.5.10 动物试验
  • CH3.5.11 可用性/人为因素
• CH3.6 非临床研究文献 CR
• CH3.7.1 产品稳定性 CR
• CH3.7.2 包装验证 CR
• CH3.8 其他资料 CR

第4章 临床评价资料

• CH4.1 章节目录
• CH4.2.2 临床试验资料
• CH4.3 伦理委员会批准的相关文件 CR
• CH4.5 其他临床证据 CR

第5章 产品说明书和标签样稿

• CH5.1 章节目录
• CH5.2 产品/包装标签
• CH5.3 使用说明书
• CH5.5 医生使用说明书 CR
• CH5.6 患者使用说明书 CR
• CH5.7 技术人员/操作人员使用手册 CR
• CH5.10 其他说明书标签材料 CR