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CATÉGORIE: CLINICAL
Suivi clinique post-commercialisation (PMCF)
Un processus continu de collecte et d'évaluation proactives des données cliniques des dispositifs déjà sur le marché.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
PMCF is a proactive clinical data collection process under EU MDR for devices already on the market. It is part of PMS and clinical evaluation updates—not a one-time study after launch.
PROCESS / STEPS
- Draft a PMCF plan tied to residual risks and CER questions.
- Choose methods: registries, PMCF studies, literature, user surveys, real-world data—proportionate to class.
- Define endpoints, sample size rationale, and analysis frequency.
- Execute and document results in a PMCF evaluation report feeding CER and PSUR where applicable.
- Update risk management and labeling if new residual risks emerge.
EXAMPLES
- Implantable Class III devices often need ongoing registry-style PMCF.
- Lower-risk devices may rely more on literature + complaint trending, still documented as PMCF activities.
RELATED GUIDES & TOOLS
SOURCES
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