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).

About swissdamed

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.

Planned releases

MVP: Minimum Viable Product

Pilot phase

In June 2023, a pilot phase was undertaken with 17 companies which volunteered to test module 1 of swissdamed, dedicated to the registration of companies and economic operators. The tests were carried out successfully and the constructive feedback and comments raised some interesting points, which will allow us to make additional improvements to the swissdamed platform before it goes live in early 2024.

swissdamed survey

Swissmedic conducted a survey on swissdamed in spring 2023. The aim was to establish the “master data reality” in Switzerland in order to be able to set the right priorities when developing the module for registering medical devices. The swissdamed team was pleased to receive more than 450 valuable responses and has been delighted by the active cooperation of manufacturers, importers and authorised representatives as well as healthcare institutions.

The results are available in English in the SURVEY RESULTS REPORT.