欧盟医疗器械注册临床评价主要参考法规

文件名称

产品类别

MDR

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

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑