How to tackle PMCF for your Medical Device under the EU MDR
How to tackle PMCF for your Medical Device under the EU MDR
10 PagesHow to tackle PMCF for your Medical Device under the EU MDR According to the KPMG/RAPS survey results published in September 2019, 43% of Medical Device respondents had not started updating their Post-Market Surveillance (PMS) procedures, and 13% didn't even have a PMS strategy in place. The Medical Device Regulation (MDR) deadlines are closing in for re-certification and/or the introduction of new products. This requires manufacturers to start Post-market Clinical Follow-up (PMCF) activities to fulfill the requirements set out in Annex XIV, part B of the MDR. PMCF plays a big role in the new requirements for PMS introduced by the MDR. But the lack of guidance from the European Commission leaves many uneasy and unsure of how to implement PMCF to comply with
