Implementation of EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
Switzerland is implementing updates related to the new EU MDR and IVDR regulations for medical devices and in vitro diagnostics. The regulatory framework includes provisions on conformity assessment bodies, applicable legal acts, standards, and transitional measures for market access.
🔖 Status: in-development
This reform is part of Swissmedic's ongoing programme to modernise and strengthen the Switzerland medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗