MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

European Union · Last verified: 2026-09-08

Number

MDCG 2022-18

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「Other topics」专题，委员会指南清单页标注的发布时间为 December 2022；内容为「MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate」。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。

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