PMCF (Post-Market Clinical Follow-up)
What is it?
PMCF is the medical device equivalent of ongoing safety monitoring: a continuous process, required under EU medical device regulation, that confirms a device's safety and performance stays acceptable throughout its time on the market. It's the device world's answer to a question drugs already have PASS and RMP updates for.
Devices often reach the market on a thinner pre-market evidence base than drugs do, so PMCF carries more weight there. It typically involves collecting real-world clinical data on the device in actual use, feeding straight back into the manufacturer's risk management file.
Common Misconceptions
"The device already passed its conformity assessment. Isn't PMCF just paperwork at that point?"
Pre-market conformity assessments for devices are often based on far less clinical data than a drug's approval dossier. PMCF is how manufacturers keep confirming, with real usage data, that the device performs the way the pre-market case assumed it would.
