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    PSUR (IVDR Specific)

    Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.

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

    Definition

    Class C and D IVDs require annual PSURs; Class B IVDs require PSURs at least every two years; Class A is exempt. PSURs summarize PMS data, benefit-risk re-evaluation, sales volumes, and PMPF status.

    What this means in practice

    Closely linked to the Summary of Safety and Performance (SSP) for high-risk IVDs and reviewed by Notified Bodies for Class C/D devices.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1FDA·2
    1. 1
      IVDR Article 81
      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.