Article 10a Decision tree

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「Article 10a – interruption or discontinuation of supply」专题,委员会指南清单页标注的发布时间为 April 2026;内容为「Article 10a Decision tree」。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/c6032b3e-a8c6-4be5-9d61-ce6a7e4c

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

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