MDR Art. 86
Periodic safety update report (PSUR)
Obligation to draw up a PSUR for class IIa, IIb and III devices
- Category
- Post-market
- Market
- European Union
- Applicable classes
- Class IIa medical device, Class IIb medical device, Class III medical device
- Applicable since
- May 26, 2021
In practice
Frequency: at least annually for classes IIb and III, at least every two years for class IIa. Class I falls under the post-market surveillance report of Article 85, not the PSUR. Must include an updated benefit-risk analysis.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745#d1e11222-1-1See where this text lands in your roadmap
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