Post-Market Clinical Follow-up
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
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. A PMCF plan sets out the methods, objectives and timelines, and results go into a PMCF evaluation report that feeds the benefit-risk determination. Manufacturers can justify not running PMCF studies, for example for well-established technologies, but must document why. MDCG 2020-7 and 2020-8 provide templates for the plan and report.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.
- •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
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPeriodic EU MDR/IVDR report summarizing post-market surveillance findings.
Activities to monitor device safety and performance after market release.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
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· Same categoryExpedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Communication to users notifying them of a safety issue, corrective action, or important product information.
FDA's mandatory electronic submission system for Medical Device Reports.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDCG 2020-7 PMCF Plan TemplateTier 2 VerifiedMDCGhealth.ec.europa.eu
- 2FDA MAUDE DatabaseTier 2 VerifiedFDAaccessdata.fda.gov
- 3FDA Recalls - Medical DevicesTier 2 VerifiedFDAfda.gov
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