/ Regulatorik

Implementation of EU-Medical Device Regulation postponed by one year

In view of the current situation, the EU commission and parliament have decided to postpone the implementation of the "Medical Device Regulation (MDR)" by one year. The new regulations should have come into force at the end of May 2020.

For Switzerland, the goal of maintaining equivalence with EU law remains. For this reason, the implementation of the revised Swiss Medical Devices Act will also be postponed by one year to 26 May 2021. The In Vitro Diagnostics Regulation (IVDR) is not affected by this postponement.