PMCF
Post-Market Clinical Follow-Up · post-market clinical follow-up
Proactive, planned collection and evaluation of clinical data on a CE-marked device to confirm safety and performance throughout its expected lifetime (EU MDR).
PMCF is a mandatory part of EU MDR post-market surveillance for most devices: a documented PMCF Plan defines how clinical evidence is gathered (registries, surveys, follow-up studies), and a PMCF Evaluation Report feeds into the Periodic Safety Update Report (PSUR) and updates the Clinical Evaluation Report (CER).
V5 links PMCF plan, data collection, complaints, and PSUR/CER output into one device dossier so the clinical loop closes back into design controls and risk management.
- EU MDR Annex XIV Part B
- MDCG 2020-7
- MDCG 2020-8
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