MDR 2017/745
Regulation (EU) 2017/745 on medical devices
The core regulation governing the placing of medical devices on the EU market
- 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
The MDR replaces Directives 90/385/EEC and 93/42/EEC. It has applied since 26 May 2021, but devices still covered by a certificate issued under those directives benefit from a transitional period extended by Regulation (EU) 2023/607: 31 December 2027 for class III and implantable class IIb devices, 31 December 2028 for the other classes requiring a notified body.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745See where this text lands in your roadmap
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