Guide
What is PMCF? Post-market clinical follow-up explained
Post-market clinical follow-up (PMCF) is the ongoing process of collecting and evaluating clinical data on a CE-marked device once it is on the market. Under EU MDR Annex XIV Part B, manufacturers must plan it, run it, and feed the results back into the clinical evaluation and risk management.
The basics
What PMCF has to achieve
Confirm safety and performance
Show that the device keeps performing as intended and stays safe across its expected lifetime.
Find unknown risks
Identify previously unknown side-effects, monitor known ones, and spot emerging risks from real-world use.
PMCF plan and evaluation report
The plan sets out methods such as registries, studies and surveys. The evaluation report analyses the results; MDCG 2020-7 and 2020-8 provide templates for both.
Part of post-market surveillance
PMCF outputs feed the clinical evaluation report, the PMS plan, the PSUR and, where required, the summary of safety and clinical performance.
Running it
A workable PMCF cycle
- 1Identify the clinical questions and residual risks left open by the clinical evaluation.
- 2Choose proportionate methods — a registry, a PMCF study, user surveys or literature review.
- 3Write the PMCF plan with objectives, endpoints, sample size and timelines.
- 4Collect data with follow-up windows, safety event capture and an audit trail.
- 5Write the PMCF evaluation report and update the clinical evaluation, risk file and PSUR.
Where Qevatrix fits
Registry data that becomes the PMCF report
EvidenceOS runs device registries with follow-up windows, outcome scores and safety triage, and produces the PMCF / registry report from live data rather than rebuilding it by hand.
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This guide is an orientation, not regulatory advice. Confirm requirements against EU MDR Annex XIV, the current MDCG guidance and your notified body's expectations.