KATEGORIE: SAFETY SURVEILLANCE

Regelmäßiger Sicherheitsbericht (PSUR)

Ein Bericht, der die Ergebnisse der Post-Market-Überwachungsdatenanalyse zusammenfasst. Unter EU MDR für Klasse IIa, IIb und III in regelmäßigen Abständen erforderlich.

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

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

EU MDR PMS/PSUR context ↗

Track regulatory signals related to Regelmäßiger Sicherheitsbericht (PSUR) across 27 authorities in real time.

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