At European level, the main organisations for the coordination and the governance of the medical devices sector are the European Commission, the National Competent Authorities and notified bodies. Several structures exist that allow for the coordination between various parties, for example the Medical Devices Coordination Group (MDCG), established by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices with specific obligations and rules, the Notified Body Coordination Group - NBCG-Med, established in accordance with Article 49 MDR and Article 45 IVDR and containing all notified bodies designated under the MDR and the IVDR and the Competent authorities for Medical Devices (CAMD); informal forum that facilitates implementing and enforcing the Regulations on medical devices and on In Vitro Diagnostic medical devices
At international level, the European Union is active in a number of policy and regulatory dialogues with EU’s key partner in medical technologies. This cooperation takes place both in bilateral and multi-lateral forums mainly through the International Medical Device Regulators Forum (IMDRF).
