Swiss medical device laws to align with the European MDR and IVDR

Switzerland is planning to transition their medical devices law in stages to align with the European MDR and IVDR, with the changes mirroring European Union (EU) member states. The aim is to ensure that Switzerland can continue to participate as an equal partner in the EU market for medical devices.

By collaborating with the competent authorities of the EU Member States, Swissmedic can continue its effective and efficient market supervision of medical devices, thus for Swiss device manufacturers, access to the EU market will be maintained.

Back in October 2017, an early revision of Switzerland’s Medical Devices Ordinance (MedDO) was conducted in order for Swiss conformity assessment bodied to register as designated bodies according to the new EU regulations as of 26th November 2017.

The completed revision of the MedDO and a new ordinance for in vitro diagnostics will affiliate with all provisions of the EU regulations, and are expected to enter into force in the first half of 2020.

The Swiss Federal Office of Public Health (FOPH) has stated that “adjustments, in particular to the Therapeutic Products Act (TPA) and to the Human Research Act (HRA), aim to build a solid statutory basis for a complete overhaul of the MedDO as well as a new Ordinance for in vitro diagnostics”.

To read more about the revision of the medical device laws in Switzerland, please click here.