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類別: SAFETY SURVEILLANCE

定期安全更新報告(PSUR)

總結上市後監管數據分析結果和結論的報告，包括任何預防或糾正措施的理由。EU MDR要求IIa、IIb和III類器材定期提交。

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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相關術語

上市後監管(PMS)警戒EU MDR (法規2017/745)