目标、输入和待评价产品信息

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.