制造商产生的数据

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).