技术文件的要求
MDR中添加了对技术文件内容的要求；且明确指出上市后监管计划和安全性更新报告（PSUR）都是技术文件的一部分，并要求依据上市后监管体系收集的资料对技术文件中相应信息进行更新。
技术文件的基本内容
1.器械说明与性能指标
2.包括变型和附件包含器械说明与性能指标，以及引用的前代和类似器械的信息。
3.制造商提供的信息
4.设计与制造信息
5.通用安全与性能要求
6.包含其符合附录I提供的通用安全与性能要求的证明资料。
7.风险利益分析和风险管理
8.产品验证与确认
9.临床前和临床数据（包含临床评价计划/报告，PMCF计划/报告）；以及针对含药器械、人体/动物来源组织或其衍生物制备的器械、引入人体并被吸收器械、具有测量功能器械等的相关附加信息
Requirements of technical documents
Requirements for contents of technical documents are added inMDR; It is also clearly pointed out that the post marketingregulatory plan and the security update report (PSUR) are part ofthe technical documents, and it is required to update thecorresponding information in the technical documents according tothe data collected by the post marketing regulatory system.
Basic contents of technical documents
1. Device description and performance index
2. Including variants and accessories, including devicedescription and performance indicators, as well as information ofprevious generation and similar devices.
3. Information provided by the manufacturer
4. Design and manufacturing information
5. General safety and performance requirements
6. Include the documents proving its compliance with the generalsafety and performance requirements provided in Appendix I.
7. Risk Benefit Analysis and Risk Management
8. Product Verification and Validation
9. Pre clinical and clinical data (including clinical evaluationplan/report, PMCF plan/report); As well as relevant additionalinformation on medical devices, devices prepared from human/animaltissues or their derivatives, devices introduced into human bodyand absorbed, devices with measurement functions, etc
