Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance)

European Union · Last verified: 2026-09-08

Number

32023R0607

Type

Regulation

Issuer

European Parliament and Council of the European Union

Status

in_force

Authority

欧盟委员会 / MDCG

What this covers

延长 MDD/AIMDD 遗留器械证书的过渡期并取消器械「售罄日期」，是目前 MDR 过渡安排的核心依据；延期以满足质量管理体系与申请时限等条件为前提。

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