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    Post-Market Performance Follow-up

    IVDR equivalent of PMCF - ongoing collection of performance data for in vitro diagnostics.

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

    Definition

    PMPF activities (IVDR Annex XIII Part B) confirm continuing safety, performance, and clinical benefit of IVDs in real-world use. Required for all IVDs unless absence is justified.

    What this means in practice

    Increasingly important as IVDR transition timelines force legacy devices into structured post-market data collection.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1MDCG·1FDA·1
    1. 1
      IVDR Annex XIII
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      MDCG Vigilance Guidance
      Verified
      MDCGhealth.ec.europa.eu
    3. 3
      FDA MAUDE Database
      Verified
      FDAaccessdata.fda.gov

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