Background
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, including in vitro diagnostic medical devices, is 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 in 2026 in MedDO and IvDO, as the database required for this purpose must first be made available (Art. 110 MedDO and Art. 91 IvDO).
About swissdamed
swissdamed – swiss database on medical devices – is a Swissmedic database that makes it possible to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices.
It is structured around two modules, which only registered users can access. It also includes a freely accessible search function. The individual modules are being made available in stages.
- Actors module: Registration of companies and economic operators
- available from August 2024
- swissdamed – freely accessible platform with search function
- available from August 2024
- Devices module: registration of devices
- Currently in development.
- Sections of the Devices module will be made available in 2025 for the registration of certain devices on a voluntary basis.
Pilot phase
To date, two pilot phases have been completed with Swiss economic operators. In June 2024, Swiss manufacturers tested the mass upload of Regulation Devices in the XML format. In June 2023, a pilot phase was undertaken in order to test the Actors module for the registration of companies and economic operators.
The tests were completed successfully, and the constructive feedback and comments raised some interesting points. This enabled Swissmedic to make additional improvements to swissdamed.
Additional functions are planned in future with the close involvement of stakeholders.