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    Post-Market Performance Follow-up

    The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

    Definition

    Annex XIII Part B of the IVDR requires manufacturers to plan and conduct PMPF as a continuous process that updates the performance evaluation. The PMPF plan specifies methods and procedures for collecting and evaluating clinical performance and safety data, and results are reported in a PMPF Evaluation Report that feeds the Performance Evaluation Report and the PSUR (Class C and D) or PMS Report (Class A and B).
    What the regulation says
    The EU IVDR (Regulation (EU) 2017/746) mandates Post-Market Performance Follow-up (PMPF) as a continuous process to update the performance evaluation. This includes collecting and assessing performance and scientific data from the use of an IVD that bears the CE mark, as specified in IVDR Annex XIII Part B. The FDA also expects manufacturers to monitor device performance post-market, although typically through adverse event reporting and other surveillance activities rather than a dedicated PMPF process as detailed in the IVDR.

    What this means in practice

    PMPF is not optional. When a manufacturer concludes PMPF is not applicable, the rationale must be documented and justified. Registry participation and reflex-testing agreements with clinical laboratories are common PMPF data sources.

    Examples

    • A manufacturer of a novel immunoassay for a specific biomarker conducts PMPF by establishing a registry study to monitor assay performance in various clinical settings and patient populations over two years.
    • For an IVD used in point-of-care settings, the manufacturer implements a PMPF plan that includes active feedback channels from users and periodic site visits to observe device usage and collect performance data.
    • A company offering a high-risk companion diagnostic IVD includes a PMPF activity to track the incidence of false positive/negative results and their impact on patient management by collaborating with clinical laboratories.
    Common pitfalls
    • •Confusing PMPF with general post-market surveillance activities, as PMPF has specific requirements for data collection and analysis under the IVDR.
    • •Failing to establish a PMPF plan or justify its absence for every IVD, which is a key IVDR requirement.
    • •Not sufficiently linking PMPF findings back to the performance evaluation report and clinical evidence, thus missing the iterative improvement aspect.
    • •Using only passive surveillance data for PMPF when active data collection is necessary to address specific performance questions.
    • •Underestimating the resources and expertise required to effectively conduct PMPF activities and analyze the resulting data.

    Frequently asked questions

    The primary goal of PMPF is to proactively collect and evaluate performance data from IVDs in real-world use to confirm their continued safety, performance, and clinical benefit, updating the performance evaluation accordingly.
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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    EUR-Lex·1MDCG·1FDA·1
    1. 1
      Regulation (EU) 2017/746, Annex XIII Part B
      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.