Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

European Union · Last verified: 2026-09-08

Number

MDCG 2021-13 rev.1

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 July 2021；内容为「Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR」。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。

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