MDR Art. 10
General obligations of manufacturers
Sets out the manufacturer’s obligations: compliant design, technical documentation, declaration of conformity, CE marking
- 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 manufacturer must: 1) design to the general safety and performance requirements 2) draw up the technical documentation 3) put a quality management system in place 4) draw up the EU declaration of conformity 5) affix the CE marking.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745#d1e1987-1-1See where this text lands in your roadmap
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