Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

European Union · Last verified: 2026-09-08

Number

MDCG 2021-22 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「In Vitro Diagnostic medical devices (IVD)」专题，委员会指南清单页标注的发布时间为 September 2022；内容为「Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746」。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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