PSUR MDCG-2022-21 定期安全更新报告模板.docx

PSUR 模板简介 This template includes the Annexes from MDCG 2022-21 on Periodic Safety Update Reports (PSURs). 本模板包括MDCG 2022-21关于定期安全更新报告(PSURs)的附录。 该模板提供了一些额外的上下文，这些上下文用蓝色突出显示。 模板的说明: All text under the section titles should be reviewed and then replaced with your information.所有章节标题下的文本都应检查，然后替换为您的信息。 Delete the blue highlighting from the final document. 从最终文档中删除蓝色高亮显示。 PSUR Sections: Cover Page Table of Contents封面和目录 Executive Summary 摘要 Description of the devices covered by the PSUR and their intended uses (Article 86.1) PSUR所涵盖的设备及其预期用途的描述 Volume of Sales (Article 86.1) 销量 Size and other characteristics of the population using the device (Article 86.1) 使用该设备的人群的规模和其他特征 Post-Market Surveillance: Vigilance and CAPA information 上市后监督：警戒和CAPA信息 Post-Market Surveillance: Information including general Post-Market Clinical Follow-up (PMCF) Information (Annex III and Annex XIV, Part B, 6.2(a) and (f) MDR) 上市后监督：信息包括上市后临床随访(PMCF)信息 Specific Post-Market Clinical Follow-up (PMCF) Information (Article 86, MDR Annex XIV, Part B, 6.2(b)) 具体的上市后临床随访(PMCF)信息 Summary of Findings and Conclusions of the PSUR PSUR调查结果和结论摘要 The template below provides details on how to populate each section. 下面的模板提供了如何填充每个部分的详细信息。 ANNEX I: Template for the PSUR (This is the Template intro text from MDCG 2022-21) The PSUR should be generated as a stand-alone document that can be assessed independently from the supporting documentation. PSUR应作为独立文件生成，可以独立于辅助文件进行评估。 The PSUR should provide a general overview of all post-market surveillance activities and the data collected and analyzed based on the PMS plan for the device. Therefore, the aim of the PSUR is not to duplicate all data and reports generated by the PMS Plan but instead to summarize all results and conclusions. PSUR应提供所有上市后监督活动的总体概述，以及根据器械PMS计划收集和分析的数据。因此，PSUR的目的不是复制PMS计划产生的所有数据和报告，而是总结所有结果和结论。 The manufacturer should specify the relevant information and sections of the different reports and provide a summary of the data collected, their