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CATÉGORIE: SAFETY SURVEILLANCE

Rapport périodique actualisé de sécurité (PSUR)

Un rapport résumant les résultats de l'analyse des données de surveillance post-commercialisation. Requis sous l'EU MDR pour les dispositifs de Classe IIa, IIb et III à intervalles réguliers.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Periodic Safety Update Reports summarize PMS data and conclusions for applicable EU MDR device classes on defined intervals.

PROCESS / STEPS

  1. Define data sources and reporting period.
  2. Analyze complaints, vigilance, PMCF, and literature.
  3. Document benefit-risk conclusions and actions.
  4. Submit/archive per MDR and NB expectations.

EXAMPLES

  • Class III devices typically require more frequent PSUR cadence than lower classes.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Surveillance post-commercialisation (PMS)VigilanceEU MDR (Règlement 2017/745)