IVDR 2017/746
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
The core regulation governing in vitro diagnostic devices in the EU
- Category
- Founding texts
- Market
- European Union
- Applicable classes
- Class A IVD, Class B IVD, Class C IVD, Class D IVD
- Applicable since
- May 26, 2022
In practice
Replaces Directive 98/79/EC. Applies since 26 May 2022. Four risk classes, A to D.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0746See where this text lands in your roadmap
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