All terms
Post-Market Clinical Follow-up
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
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.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.Cross-references
Part of
A larger framework or document this term belongs to.
Precedes
Comes before in a typical workflow or lifecycle.
Follows
Comes after in a typical workflow or lifecycle.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
MDCG·1FDA·2
- 1
MDCG 2020-7 PMCF Plan TemplateVerifiedMDCGhealth.ec.europa.eu
- 2
FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3
FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.