Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation ( IVDR )

European Union · Last verified: 2026-09-08

Number

MDCG 2021-16 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「Notified bodies」专题，委员会指南清单页标注的发布时间为 January 2025；内容为「Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation ( IVDR )」。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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