Post-market clinical follow-up (PMCF)

PMCF belongs to both the clinical evaluation and the post-market surveillance plan, and it follows a written PMCF plan. It confirms safety and performance over the device's expected lifetime, checks that known risks stay acceptable and looks for emerging risks, off-label use and misuse. The findings go into a PMCF evaluation report, which is part of the clinical evaluation report and feeds risk management.

5. PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

EU MDR, Annex XIV, Part B, Section 5

The FDA has no general PMCF requirement. Postmarket clinical data are required in the US only in specific cases, such as conditions of a PMA approval or postmarket surveillance ordered under section 522 of the FD&C Act (21 CFR 822).