Medical Devices

Medical device regulation covers the safety, performance, and market access of devices from bandages to implantable and software-based products. In the EU it is governed mainly by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), which set conformity assessment, clinical evidence, notified body, and post-market surveillance requirements. This page collects the updates HealthSignal tracks on device classification, CE marking, notified body designations, guidance from the Medical Device Coordination Group, and national implementation, all from official public bodies.