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Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.

European Union · Last verified: 2026-09-08

Number
MDCG 2020-3 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 September 2023;内容为「Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.」。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。

Official text: https://health.ec.europa.eu/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d

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Facts only; not legal advice. The official current text prevails.