In the absence of an operational agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA), registration of economic operators (CHRN) and unique device identification (UDI) is carried out directly by Swissmedic.
Coupled with the requirements of device registration in connection with the MedDO (Medical Devices Ordonance, SR 812.213) and the IvDO (Ordinance on In Vitro Diagnostic Medical Devices, SR 812.219), the obligations and modalities associated with Articles 27, 29 and Annex VI of the EU-MDR (Regulation 2017/745 on Medical Devices) and with Articles 24, 26 and Annex VI of the EU-IVDR (Regulation 2017/746 on in vitro diagnostic medical devices) apply to manufacturers. The MedDO and IvDO Articles on device registration will come into force at a later date (see Art. 110 MedDO / Art. 91 IvDO), as the database required must be available first.
Swissmedic is currently designing this database. It will register economic operators in addition to medical devices. Due to the continuing aim of equivalence between regulations in Switzerland and the EU, the medical devices database will be similar to EUDAMED. It will be possible to register medical devices by mass upload.
Economic operators who are already registered with Swissmedic (Swiss unique registration number, CHRN) will not be required to register again in the new medical devices database (data migration).
Swissmedic will communicate a schedule for the new database by the middle of this year. Relevant specifications for stakeholders will also be published here.