Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860

European Union · Last verified: 2026-09-08

Number

Q&A

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「Other topics」专题，委员会指南清单页标注的发布时间为 July 2024；内容为「Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860」。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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