IVDR Art. 57 à 77
Performance studies
Procedure applying where a performance study falls under the regulated regime: application, ethics opinion, event reporting
- 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
Not every study triggers the full procedure: it targets interventional studies and those involving a dedicated specimen collection. Application through the electronic system of Article 69, completeness response within 10 days, favourable ethics committee opinion required in all cases. A substantial modification is notified within one week and applies no earlier than 38 days later (Article 71). The end or halt of a study is reported within 15 days, or within 24 hours where the halt is for safety reasons (Article 73).
Official sources
https://eur-lex.europa.eu/eli/reg/2017/746/oj/fraSee where this text lands in your roadmap
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