MDCG 2020-10/2 rev.1

European Union · Last verified: 2026-09-08

Type
Guidance
Issuer
European Commission, DG Health and Food Safety
Status
in_force
Authority
欧盟委员会 / MDCG

What this covers

欧盟委员会器械领域指导文件,属「Clinical investigation and evaluation, performance studies and evaluation」专题,委员会指南清单页标注的发布时间为 October 2022;内容为「MDCG 2020-10/2 rev.1」。此类文件无强制法律效力,但代表成员国主管当局与公告机构对 MDR/IVDR 的共同解释口径。注意 effective 填的是发布月份(日补 01),不是法律生效日。

Official text: https://health.ec.europa.eu/document/download/bf136f27-27da-4a31-97c2-a5de741c

© European Union, source: EUR-Lex / European Commission. Changes made by this site: {changes}

Facts only; not legal advice. The official current text prevails.