Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013

欧盟 · 最近核对：2026-09-08

编号

MDCG 2020-11

类型

指南

颁布机关

Medical Device Coordination Group (MDCG)

状态

in_force

主管机构

欧盟委员会 / MDCG

这份文件管什么

MDCG 指南文件，属「Notified bodies」专题，委员会指南清单页标注的发布时间为 May 2020；内容为「Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013」。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。

© 欧盟，来源：EUR-Lex / 欧盟委员会。本站对原文的处理：{changes}