In vitro diagnostic medical devices; In vitro diagnostic test systems (ICS 11.100.10)

Draft ordinance on in-vitro diagnostics (52 page(s), in German; 51 page(s), in French; 50 page(s), in Italian)

On April 5, 2017, the Parliament and the Council of the European Union adopted the new Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR). By aligning Swiss medical device legislation with the two EU regulations, the safety and quality of medical devices, including in vitro diagnostics, should also be improved in Switzerland ensuring better protection of patients. In this regulation, the provisions of the EU-IVDR have been transferred into a new Swiss regulation on in vitro diagnostic medical devices.