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CATEGORY: SAFETY SURVEILLANCE
Periodic Safety Update Report (PSUR)
A report summarizing the results and conclusions of post-market surveillance data analysis, including the rationale for any preventive or corrective actions. Required under EU MDR for Class IIa, IIb, and III devices at regular intervals.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
- Define data sources and reporting period.
- Analyze complaints, vigilance, PMCF, and literature.
- Document benefit-risk conclusions and actions.
- Submit/archive per MDR and NB expectations.
EXAMPLES
- Class III devices typically require more frequent PSUR cadence than lower classes.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Periodic Safety Update Report (PSUR) across 27 authorities in real time.
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