Successful postmarket clinical follow-up plans (PMCFs) should be able to provide new information that was not previously known about a device, such as delayed hypersensitivity reactions or thrombosis, asserted Breda Kearney, clinical regulatory lead for BSI at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 24 October.
She said that “PMCF studies are not just mandatory exercises to collect more data on the same known information.” Under a PMCF, sponsors collect and evaluate clinical data from use of the device after device approval.
Kearney also addressed how PMCFs differ from studies collected under the postmarket surveillance (PMS) system and outlined some common issues observed in PMCFs.
The Medical Device Regulation (MDR) requires device manufacturers to conduct PMCFs, and these plans are an “integral” part of the PMS system, she said. Collecting this data has been accorded a higher profile under MDR compared to previous directives. Kearney said there may be circumstances where certain devices may not need a PMCF, but manufacturers must provide justification for not submitting one…
