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    Periodic Safety Update Report

    Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Per EU MDR Article 86, the PSUR summarizes results and conclusions of analyses of post-market surveillance data, including main findings of the PMCF, the rationale and description of preventive and corrective actions, and the volume of sales.

    What this means in practice

    PSUR frequency depends on device classification. Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1FDA·2
    1. 1
      EU MDR Article 86
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      FDA MAUDE Database
      Verified
      FDAaccessdata.fda.gov
    3. 3
      FDA Recalls - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.