The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)). In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs. As such, the MDCG has suggested actions for mitigating such challenges. Importantly, there is a focus on flexibility and pragmatism.
Continue Reading Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability