Since the agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA) has not been updated, registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (product identification, UDI) is carried out directly by Swissmedic.
Coupled with the requirements of device registration in the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), the obligations and modalities associated with Articles 27, 29 and Annex VI of the EU-MDR[1] and Articles 24, 26 and Annex VI of the EU-IVDR[2] apply to manufacturers.
Implementation of abovementioned articles in the MedDO and IvDO is following at a later date as the database required first has to be made available (Art. 110 MedDO and Art. 91 IvdDO).
Swissmedic began implementation of the “swissdamed” database in April 2022. Swissdamed stands for “Swiss Database on Medical Devices”.
Swissdamed comprises two linked modules and a public website. 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 swissdamed modules will be similar to the corresponding EUDAMED modules. It will be possible to register medical devices by mass upload.
Economic operators who register with Swissmedic before swissdamed becomes available and therefore have a unique Swiss registration number (CHRN) will not have to register again.
Swissdamed will be rolled out in three releases. The first release will cover the registration of economic operators. The second release will enable registration of medical devices. Swissmedic intends to involve selected economic operators in the realisation phase. Additional functions in the modules already implemented will be introduced in the third release.
Relevant specifications / additional information will be published here.
Registration will only become compulsory with the relevant amendment to the MedDO / IvDO – the go-live is planned for 2023.