Online Course: Update Medical Device Regulation
AMS developed together with KKS Heidelberg, Department for Advanced Training and Metecon GmbHDepartment for Advanced Training and Metecon GmbH an online course on implications of the Medical Device Regulation for clinical investigations (in German)
The new Medical Device Regulation (MDR) 2017/745, its implementation and the adaptation of national laws to the MDR pose major challenges for all those involved in clinical research with medical devices. Since the MDR came into force on 26 May 2021, manufacturers, notified bodies, authorities, ethics committees and investigational sites are faced with a considerable number of new and complex tasks and requirements. With this brief but concise Regulatory Update we give an overview on relevant aspects of planning and performing different types of clinical investigations and PMCF studies including statistical considerations as well as safety and vigilance reporting. We highlight the changes to be observed when submitting clinical investigations and PMCF studies to competent authorities and ethics committees and we describe the responsibilities of the investigational sites and the required qualification of their team members.