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类别: SAFETY SURVEILLANCE

定期安全更新报告(PSUR)

总结上市后监管数据分析结果和结论的报告，包括任何预防或纠正措施的理由。EU MDR要求IIa、IIb和III类器械定期提交。

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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相关术语

上市后监管(PMS)警戒EU MDR (法规2017/745)