Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods

European Union · Last verified: 2026-09-08

Number
Q&A rev.2
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「Other topics」专题,委员会指南清单页标注的发布时间为 July 2024;内容为「Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods」。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/592008f6-3456-4afb-a13a-733a87da

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

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