Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket follow-up period, Richard Holborow, head of clinical compliance at BSI, said at the 2023 RAPS European Clinical and Risk Management Conference.
“Premarket data are obviously key to getting the device to market because it’s done in a controlled, methodological manner, following certain rules,” Holborow told Focus. “Once you’ve got your CE certificate, because that device is going out to all physicians to be able to use in Europe, then we expect that there are activities to capture that data.”
Holborow provided an overview of RWD from the perspective of a notified body and noted that, under the EU Medical Device Regulation (MDR), manufacturers are expected to commit to postmarket clinical follow-up (PMCF). This is where RWD and real-world evidence (RWE) can provide critical information on how the device performs during actual clinical use, he said…
