Normiq
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MDR Art. 120

Transitional provisions

Regime applying to devices still covered by a certificate issued under the old directives

Category
Founding texts
Market
European Union
Applicable classes
Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
Applicable since
May 26, 2021

In practice

Rewritten by Regulation (EU) 2023/607. End of the period: 31 December 2027 for class III and implantable class IIb devices, 31 December 2028 for other class IIb, class IIa and class I devices requiring a notified body. Cumulative conditions: design and intended purpose unchanged, compliant quality management system and application lodged with a notified body by 26 May 2024, written agreement signed by 26 September 2024. During the period, post-market surveillance, vigilance and registration already fall under the MDR.

Official sources

https://eur-lex.europa.eu/eli/reg/2023/607/oj/fra

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