MDCG publishes guidance on the transition from the ‘EC REP’ to the ‘EU REP’ symbol
The MDCG has published an appendix to MDCG 2021-5 clarifying the transition from the 'EC REP' to the 'EU REP'symbol under EN ISO 15223-1, including a five-year transition period for medical device and IVD manufacturers.
Swissmedic publishes updated swissdamed Playground User Guide
Swissmedic has published Version 3.0 of the swissdamed User Guide – Playground, providing updated instructions for testing actor registration and UDI management before using the production environment.
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.
European Commission publishes EUDAMED Release Notes v2.25.2
The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.