Vigilance reports are a crucial part of a systematic and integrated post-market surveillance (PMS) system established through the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure the safety of medical devices. In addition, in the current PMS system, manufacturers must systematically and actively collect, analyse, and review experience gained from devices placed on the EU market.
The Notified Bodies do not serve as primary operational actors in the vigilance system established by the regulations; instead, they play a supportive role by auditing the implementation of vigilance procedures, assessing vigilance data that may impact certification as part of their audits, and liaising with competent authorities when relevant. Nevertheless, some Notified Bodies interpret that they must review every serious incident report a manufacturer submits to comply with the new regulations, which leads to duplicate reviews by Notified Bodies and competent authorities and creates an unnecessary burden.
MedTech Europe calls on the European Commission and the Medical Device Coordination Group (MDCG) to streamline vigilance data evaluation processes under MDR and IVDR to eliminate duplicate reviews of vigilance cases.
Read MedTech Europe’s full reflections on the role of Notified Bodies in vigilance data review in the position paper below.