Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (Text with EEA relevance)

European Union · Last verified: 2026-09-08

Number

32022R0112

Type

Regulation

Issuer

European Parliament and Council of the European Union

Status

in_force

Authority

欧盟委员会 / MDCG

What this covers

为部分 IVD 设定分层过渡期，并推迟院内自制器械（in-house devices）相关条件的适用，缓解 IVDR 切换压力。

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