Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market.
Notified Bodies are not primary actors in the vigilance system but play a supporting role by auditing vigilance procedures, assessing relevant data during certification audits, and coordinating with competent authorities when necessary. However, some Notified Bodies interpret their role as requiring them to review every serious incident report submitted by manufacturers, leading to redundant evaluations by both Notified Bodies and competent authorities, increasing regulatory burden.
MedTech Europe urges the European Commission and the Medical Device Coordination Group (MDCG) to streamline vigilance data evaluation under MDR and IVDR, reducing unnecessary duplication of reviews.
The position paper can be accessed using the following link
