MDR Annexe I
General safety and performance requirements
The essential requirements every device must satisfy
- 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
Covers design, materials, biocompatibility, instructions for use, risks, performance and software. Conformity is demonstrated through clinical and technical evaluation.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745#d1e32-117-1See where this text lands in your roadmap
Normiq places every deadline in your device's roadmap, with the steps that lead to it. Free 7-day trial.
Start the free trial