Glossary · EU medical devices: MDR
Post-market clinical follow-up (PMCF)
Also known as: PMCF, PMCF plan, PMCF evaluation report
Under the EU Medical Device Regulation (EU) 2017/745, post-market clinical follow-up is a continuous process that updates the clinical evaluation, in which the manufacturer proactively collects and evaluates clinical data from the use of a CE-marked device within its intended purpose. It is planned in a PMCF plan and reported in a PMCF evaluation report under Annex XIV Part B.
- EU
- MDR
In one sentence
PMCF under MDR Annex XIV Part B: the manufacturer’s continuous, proactive collection of clinical data on a CE-marked device to update its clinical evaluation.
Example
A manufacturer of a hip implant runs a PMCF plan that combines a national joint registry analysis with a five-year PMCF study and feeds the results into the clinical evaluation report and the SSCP.
How it applies
- Aims: PMCF confirms safety and performance over the expected lifetime, identifies previously unknown side effects and emerging risks, keeps the benefit-risk ratio under review and detects systematic misuse or off-label use.
- Methods: General methods include literature review and gathering clinical experience and user feedback; specific methods include registries and PMCF studies. The plan justifies the chosen mix.
- Not needed? Where PMCF is considered unnecessary, the PMS plan must justify this; the notified body reviews the justification.
- Templates: MDCG 2020-7 (PMCF plan) and MDCG 2020-8 (PMCF evaluation report) give the structure notified bodies expect.
- Technical documentation: The PMCF plan belongs to the post-market surveillance documentation; the PMCF evaluation report updates the clinical evaluation and is summarized in the PSUR and, where applicable, the SSCP.
PMCF vs. PMPF
PMCF is the MDR process for medical devices and updates the clinical evaluation. PMPF is the IVDR process for in vitro diagnostics and updates the performance evaluation, covering scientific validity and analytical and clinical performance. The names are not interchangeable.