Position Paper: UDI assignment between manufacturers and distributors

European Union · Last verified: 2026-09-08

Number
MDCG 2026-5
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「Unique Device Identifier (UDI)」专题,委员会指南清单页标注的发布时间为 July 2026;内容为「Position Paper: UDI assignment between manufacturers and distributors」。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/f34c1afd-8d01-44cc-bf94-33e4bcac

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

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