MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use

European Union · Last verified: 2026-09-08

Number
MDCG 2026-4
Type
Guidance
Issuer
Medical Device Coordination Group (MDCG)
Status
in_force
Authority
欧盟委员会 / MDCG

What this covers

MDCG 指南文件,属「EUDAMED」专题,委员会指南清单页标注的发布时间为 June 2026;内容为「MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use」。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/a80332cf-e9f0-4d45-8863-3d96e8c2

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