During the Qserve webinar on 7 December 2017, Dr. Bassil Akra from TÜV SÜD, Wiebe Postma and Loes Pelgrim from Qserve gave a comprehensive overview of the requirements for Post-market clinical follow up (PMCF) under the new EU medical device regulation (MDR).
PMCF is typically used to confirm clinical safety and performance, investigate uncertainties, residual risks, or identify previously unknown risks of medical devices. In some cases, PMCF may literally follow a clinical investigation: it is possible to extend the follow-up of patients in a pre-CE study in the post-market phase with a cross-over study design. The type of activity that is required for PMCF is not limited to manufacturer-initiated clinical investigation and can consist of many different activities such as collecting device registry data or using a questionnaire to collect user feedback. Under the new MDR also post-market literature research and analysis can be input to the PMCF report. A broad audience from device manufacturers, CRO, and independent consultants enjoyed lively presentations, which were concluded with a Q&A session.
“It was great to share our take on MDR requirements regarding PMCF with such a diverse audience. Now is the time to close the gaps in your clinical evidence. We will gladly assist you with the development and implementation of your PMCF plans."
Do you still have questions regarding PMCF? Please let us know and we will share our state of the art answers with you.
The PMCF webinar will soon be broadcasted. Keep an eye on our events page on this website.