文件名称

支持性文件

TD

TECHNICAL DOCUMENTATION

技术文档

All

ANNEX II

Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745

CEP

Clinical Evaluation Plan

临床评价计划

All

ANNEX XIV PART A 

MDCG 2020-6

Appendix II – Clinical Evaluation Plan for Legacy Devices

PMCF Plan

Post-market clinical follow-up Plan

上市后临床跟踪计划

All

ANNEX XIV PART B

MDCG 2020-7

PMCF Evaluation Report

Post-market clinical follow-up (PMCF) Evaluation Report

上市后临床跟踪报告

All

Annex XIV Part B

MDCG-2020-8

PMS Plan

Post-market surveillance Plan

上市后监督计划

All

Article 84

ISO 20416

PMS Report

Post-market surveillance report 

上市后监督报告

ClassⅠ

Article 85 

/

PSUR

Periodic safety update reports

定期安全更新报告

class IIa, class IIb and class III 

Article 86

MDCG-2022-21

CECP

Clinical Evaluation Consultation Procedure

临床评估咨询程序

class III implantable devices,

class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).

Article 54 

MDCG 2019-3

Summary of safety and clinical performance

安全和临床性能总结

Implantable devices and for class III devices

Article 32 

MDCG 2019-9 Rev.1