Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1

European Union · Last verified: 2026-09-08

Number

Gradual roll out of EUDAMED

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「EUDAMED」专题，委员会指南清单页标注的发布时间为 November 2024；内容为「Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1」。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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