Since the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated, registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (unique device identification, UDI) is now carried out directly by Swissmedic.
Manufacturers are subject not only to the device registration requirements stated in the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) but also to the obligations and modalities associated with Articles 27, 29 and Annex VI of the EU-MDR and Articles 24, 26 and Annex VI of the EU-IVDR.
The above-mentioned articles will enter into effect at a later date in MedDO and IvDO, as the database required for this purpose must first be made available (Art. 110 MedDO and Art. 91 IvDO).
The swissdamed application – the Swiss Database on Medical Devices – is a Swissmedic IT system that makes it possible to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices.
It is structured around two interconnected modules, which only registered users can access. It also includes a freely accessible search function.
- Registration of companies and economic operators – ACT module (available early 2024)
- swissdamed – freely accessible platform (available early 2024)
- Registration of devices – UDI module (available from summer 2024)
The above modules will be made available in different releases.