PMCF (post-market clinical follow-up)

Post-market clinical follow-up is a continuous process, under the EU MDR, for updating the clinical evaluation with data from the device's use after it is placed on the market.

PMCF is part of post-market surveillance. Annex XIV Part B of the EU MDR describes it. The manufacturer plans how clinical data will be collected to confirm safety and performance, to identify previously unknown side-effects, and to monitor identified risks and contraindications. Methods include a PMCF study, registry analysis, surveys of users, or a justified equivalent. 'No PMCF needed' is a conclusion you document, not a default.

The plan, the evaluation of the data, and the update to the clinical evaluation report belong together. A plan that is never executed is a finding. Data that never updates the benefit-risk conclusion is also a finding.

HAVGATE is not a clinical study or EDC system. Keep the QMS records that show you reviewed PMCF outputs in management review and in CAPA when the data requires a change.