MDR Art. 83
Post-market surveillance system
Obligation to establish and keep up to date a post-market surveillance system
- Category
- Post-market
- 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 surveillance plan must be proportionate to the risk class. It covers data collection, incident analysis, user feedback, and the periodic or annual safety report.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745#d1e10987-1-1See where this text lands in your roadmap
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