临床评价报告(CER)

临床评价报告（CER）是临床评价过程的最终产物，它系统地记录了按照临床评价计划（CEP）所执行的各项活动、收集到的数据、进行的分析以及得出的关于医疗器械安全性、临床性能和受益风险平衡的结论。其核心目的是证明器械符合欧盟医疗器械法规（MDR）的相关通用安全和性能要求（GSPR）。

1. 引言与背景回顾

CER的开篇部分应简明扼要地回顾在CEP中设定的临床评价目标、范围、以及待评价器械的关键信息。这包括：

• 重申目标与范围： 再次明确本次临床评价旨在确认器械的安全性和性能，以符合MDR中GSPR 1和GSPR 8等要求。清晰指出本CER是依据特定CEP执行的结果。
• 输入文件清单： 列出在评价过程中实际参考和依赖的关键文件（如风险管理报告、IFU、临床前研究报告、先前版本的CEP/CER等）。
• 器械描述概要： 准确描述被评价的器械型号、预期用途、分类等核心信息，确保读者对评价对象有清晰认识。

2. 当前技术发展水平（SOTA）的呈现

在CER中，此部分不再是规划如何研究SOTA，而是实际呈现通过执行CEP中SOTA研究计划所确立的临床背景。应包含：

• 对相关医学状况、现有治疗手段、替代方案、以及类似/基准器械的安全性和性能水平的总结。
• 列出在评价中作为参照的适用标准和指南文件。

3. 数据收集与评估结果的报告

这是CER的主体部分，详细报告按照CEP规划（特别是文献检索计划LSP和数据评估计划）收集和评估数据的实际执行情况和结果。

• 制造商持有数据的总结： 呈现已完成的临床前研究（如台架测试、生物相容性、动物实验等）的主要结果和结论。若有制造商申办的临床研究，则报告其设计、执行情况、关键安全性和性能数据。若器械已上市，则总结相关的PMS和PMCF数据。
• 文献检索与筛选结果： 详细报告文献检索的执行过程（如实际检索的数据库、日期、使用的检索式、检索到的文献数量等），并使用PRISMA流程图等方式清晰展示文献筛选流程和结果（纳入/排除的文献数量及理由）。
• 等同性论证（如适用）： 如果CEP中规划了通过等同路径进行评价，CER则需详细展示与所选等同器械在临床、技术和生物学特性方面的对比分析结果，并对所有差异的临床显著性进行论证，最终明确等同性是否成立。
• 数据评估的实施： 阐述是如何按照CEP中预设的标准和方法，对所有收集到的相关数据（包括文献数据、临床研究数据、PMS数据等）进行相关性、质量和科学有效性的评估。

4. 临床数据的综合分析与结论

这是CER的核心分析部分，旨在整合所有经过评估的相关数据，进行全面分析，并据此得出结论。

• 安全性分析： 结合所有数据源（特别是临床研究、文献中的不良事件报告、安全数据库信息等），全面评估器械的安全性特征，分析不良事件的性质、发生率、严重程度及其与器械的可能关系，并与SOTA进行比较。最终确认器械的安全性符合GSPR 1的要求。
• 性能分析： 基于临床研究数据、等同器械数据或高质量的文献数据，评估器械是否达到了其声称的临床性能指标和预期用途。将实际性能数据与SOTA或预设的可接受标准进行比较。最终确认器械的性能表现符合GSPR 1的要求。
• 受益风险分析： 在综合评估安全性和性能的基础上，进行关键的受益风险判定。清晰阐述器械的主要临床受益，权衡已识别的风险（包括剩余风险），并结合SOTA，论证器械的整体受益大于风险，其受益风险比是可接受的，符合GSPR 1和GSPR 8的要求。
• 副作用的可接受性分析： 专门讨论与器械相关的副作用，评估其性质、发生率和临床可管理性，并论证其在临床受益背景下是可接受的，符合GSPR 8的要求。

5. 风险管理活动的整合

CER应清晰说明临床评价的结果是如何与风险管理过程相互作用的。确认在风险管理文件中识别的临床风险已通过本次临床评价得到充分评估，并且所有剩余风险在临床受益的背景下均是可接受的。若临床评价过程中发现了新的风险或对现有风险的认知发生改变，应说明这些信息已反馈至风险管理系统进行更新。

6. 临床开发计划（CDP）的回顾与展望

简要回顾CEP中制定的临床开发计划的执行情况，总结已完成的活动及其对本次临床评价的贡献。同时，对未来的CDP活动，特别是上市后临床跟踪（PMCF）的持续规划，以确保对器械长期安全性和性能的持续监控和验证。

7. 最终结论

CER的结尾部分需给出一个明确、肯定的总体结论：

• 总结本次临床评价已充分证明待评价器械在预期用途下的安全性、临床性能及其声称的临床受益。
• 声明器械符合MDR中相关的通用安全和性能要求（特别是GSPR 1和GSPR 8）。
• 确认器械的受益风险比在预期使用条件下是可接受的。

8. 下次临床评价的日期

最后，根据法规要求和器械的特性，明确规定本CER的下一次更新日期或更新周期。

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The Clinical Evaluation Report (CER) is the final output of the clinical evaluation process. It systematically documents the activities carried out according to the Clinical Evaluation Plan (CEP), the data collected, the analysis performed, and the conclusions reached regarding the medical device’s safety, clinical performance, and benefit-risk balance. Its primary purpose is to demonstrate the device’s conformity with the relevant General Safety and Performance Requirements (GSPRs) of the EU Medical Device Regulation (MDR).

1. Introduction and Background Review

The opening section of the CER should briefly reiterate the clinical evaluation objectives, scope, and key information about the device under evaluation as set out in the CEP. This includes:

• Restating Objectives and Scope: Reaffirm that the clinical evaluation aimed to confirm the device’s safety and performance to meet MDR requirements like GSPR 1 and GSPR 8. Clearly state that this CER is the result of executing a specific CEP.
• List of Input Documents: Enumerate the key documents actually referenced and relied upon during the evaluation (e.g., risk management report, IFU, preclinical study reports, previous CEP/CER versions).
• Device Description Summary: Accurately describe the evaluated device model(s), intended use, classification, and other core identifying information so the reader clearly understands the subject of the evaluation.

2. Presentation of the State-of-the-Art (SOTA)

In the CER, this section is not about planning how to research the SOTA, but rather about actually presenting the clinical background established by executing the SOTA research plan from the CEP. It should include:

• A summary of the relevant medical condition, existing treatment modalities, alternative options, and the safety and performance levels of similar/benchmark devices.
• A list of applicable standards and guidance documents that served as references during the evaluation.

3. Reporting of Data Collection and Appraisal Results

This is the main body of the CER, detailing the actual execution and results of data collection and appraisal as planned in the CEP (particularly the Literature Search Protocol (LSP) and data appraisal plan).

• Summary of Manufacturer-Held Data: Present the main results and conclusions of completed preclinical studies (e.g., bench tests, biocompatibility, animal studies). If manufacturer-sponsored clinical investigations were conducted, report their design, execution, and key safety and performance data. If the device is marketed, summarize relevant PMS and PMCF data.
• Literature Search and Screening Results: Detail the execution of the literature search (e.g., databases searched, dates, search strings used, number of hits), and clearly present the literature screening process and results (number of articles included/excluded and reasons), often using a PRISMA flow diagram.
• Demonstration of Equivalence (if applicable): If the CEP planned evaluation via the equivalence pathway, the CER must detail the results of the comparative analysis of clinical, technical, and biological characteristics with the chosen equivalent device(s). It must also provide justifications for the clinical significance of any differences, ultimately concluding whether equivalence is demonstrated.
• Implementation of Data Appraisal: Describe how all collected relevant data (from literature, clinical investigations, PMS, etc.) was appraised for relevance, quality, and scientific validity, according to the pre-defined criteria and methods outlined in the CEP.

4. Comprehensive Analysis of Clinical Data and Conclusions

This is the core analytical section of the CER, integrating all appraised relevant data for a thorough analysis and subsequent conclusions.

• Safety Analysis: Based on all data sources (especially clinical investigations, adverse event reports from literature, safety database information), comprehensively assess the device’s safety profile. Analyze the nature, incidence, and severity of adverse events, their potential relationship to the device, and compare this with the SOTA. Conclude on the device’s conformity with GSPR 1 regarding safety.
• Performance Analysis: Based on clinical investigation data, equivalent device data, or high-quality literature data, evaluate whether the device achieves its claimed clinical performance and intended purpose. Compare actual performance data against SOTA or pre-defined acceptance criteria. Conclude on the device’s conformity with GSPR 1 regarding performance.
• Benefit-Risk Analysis: Critically determine the benefit-risk profile by synthesizing the safety and performance analyses. Clearly articulate the device’s main clinical benefits, weigh them against identified risks (including residual risks), and, in the context of SOTA, justify that the overall benefit outweighs the risk and that the benefit-risk ratio is acceptable, meeting GSPR 1 and GSPR 8.
• Analysis of Acceptability of Side-Effects: Specifically discuss side-effects associated with the device, assess their nature, incidence, and clinical manageability, and justify their acceptability in the context of clinical benefits, meeting GSPR 8.

5. Integration with Risk Management Activities

The CER should clearly demonstrate how the clinical evaluation findings interact with the risk management process. Confirm that clinical risks identified in the risk management file have been adequately assessed through this clinical evaluation and that all residual risks are acceptable in the context of clinical benefits. If new risks or changes in the understanding of existing risks emerged during the clinical evaluation, state that this information has been fed back into the risk management system for updates.

6. Review and Outlook of the Clinical Development Plan (CDP)

Briefly review the execution of the Clinical Development Plan outlined in the CEP, summarizing completed activities and their contribution to this clinical evaluation. Also, provide an outlook on future CDP activities, particularly ongoing planning for Post-Market Clinical Follow-up (PMCF), to ensure continuous monitoring and validation of the device’s long-term safety and performance.

7. Final Conclusions

The concluding section of the CER must provide a clear, affirmative overall conclusion:

• Summarize that this clinical evaluation has sufficiently demonstrated the safety, clinical performance, and claimed clinical benefits of the device under evaluation for its intended use.
• Declare that the device conforms with the relevant General Safety and Performance Requirements of the MDR (particularly GSPR 1 and GSPR 8).
• Confirm that the device’s benefit-risk profile is acceptable under the intended conditions of use.

8. Date of Next Clinical Evaluation

Finally, in accordance with regulatory requirements and the device’s characteristics, clearly state the date or frequency for the next update of this CER.