Progress on Swissdamed for medical devices

This post is an attempt to provide basic information about Swissdamed and progress with its availability.

What is Swissdamed

Swissdamed is the Swiss Database on Medical Devices. It is a Swissmedic IT system that will make 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. The individual modules will be made available in stages.

Why is it necessary to have Swissdamed?

Since the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated (it ceased to apply on 26 May 2021), registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (unique device identification, UDI) is carried out directly by Swissmedic.

Swissdamed is necessary to apply Swiss regulations on medical devices and in vitro diagnostic medical devices.

Manufacturers Device registration requirements in Switzerland

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).

What is the progress thus far with the availability of Swissdamed modules?
  • Registration of companies and economic operators – ACT module (available in the 2nd half of 2024)
  • swissdamed – freely accessible platform (available in the 2nd half of 2024)
  • Registration of devices – UDI module (available as a minimal viable product (MVP) 4 months after the ACT module goes live)
Further Information

Source: Swissmedic