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    Post-Market Clinical Follow-up

    Proactive collection of clinical data on a CE-marked device to confirm safety and performance.

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

    Definition

    PMCF is a continuous process under EU MDR Annex XIV Part B that updates the clinical evaluation throughout a device's lifecycle, using methods such as registries, surveys, or post-market studies.
    What the regulation says
    Under EU Medical Device Regulation (MDR) 2017/745 Annex XIV Part B, Post-Market Clinical Follow-up (PMCF) is a continuous process that proactively collects and evaluates clinical data from the use of a CE-marked medical device. This process aims to confirm the safety and performance of the device throughout its expected lifetime, identify previously unknown side effects or contraindications, and ensure the continued acceptability of the benefit-risk balance. The PMCF plan and its findings are integral to the clinical evaluation report (CER) and other post-market surveillance documentation.

    What this means in practice

    PMCF plans and evaluation reports feed into the CER, PSUR, and SSCP. A weak PMCF plan is a frequent Notified Body audit finding under MDR.

    Examples

    • A manufacturer conducts a post-market clinical study on a novel implantable device to gather long-term performance data and monitor for rare complications not observed during pre-market trials.
    • A company implements a survey for users of a diagnostic software to collect feedback on usability and identify any unanticipated performance issues in diverse clinical settings.
    • A manufacturer analyzes data from a national joint replacement registry to track the long-term survival rates and revision rates of its hip implant device.
    Common pitfalls
    • •Failing to establish a proactive and systematic PMCF plan is a common deficiency cited by Notified Bodies.
    • •Treating PMCF as a one-time activity rather than a continuous, iterative process can lead to non-compliance.
    • •Not adequately justifying why certain data collection methods, or an absence of clinical studies, are appropriate for a device is a frequent pitfall.
    • •Overlooking the need to update the PMCF plan and report based on new information or risk assessments can result in regulatory issues.
    • •Collecting data without a clear methodology or statistically sound basis undermines the validity of PMCF efforts.

    Frequently asked questions

    The primary objective of PMCF is to proactively collect and evaluate clinical data from the use of a CE-marked medical device to confirm its safety and performance, identify new risks, and ensure the ongoing acceptability of its benefit-risk profile.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Precedes

    Comes before in a typical workflow or lifecycle.

    Follows

    Comes after in a typical workflow or lifecycle.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    MDCG·1FDA·2
    1. 1
      MDCG 2020-7 PMCF Plan Template
      Verified
      MDCGhealth.ec.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.