EU MDR Establishes Comprehensive Framework for Medical Devices in the European Union
Regulation (EU) 2017/745 sets out the European regulatory framework for medical devices, covering market access, economic operators, clinical evaluation, vigilance, PMS, UDI and notified bodies.
European Commission Study Monitors Availability of Medical Devices on the EU Market
The European Commission has commissioned a study to monitor the availability of medical devices on the EU market, including dashboard data and surveys of notified bodies, economic operators and health service providers.
Swissmedic Updates swissdamed Actors User Guide: What Manufacturers and Authorised Representatives Should Know
Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.