Overview

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 and in vitro diagnostic medical devices (unique device identification, UDI) 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 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

swissdamed – 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. The individual modules are being made available in stages.

• 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)

Planned releases – status as at Q1 2024

Development of the first ACT module (Release 1.1) has been completed in functional terms. Work on the UDI module  is underway. swissdamed is to be taken into operation directly in the Swissmedic Cloud. Development of this new IT infrastructure, together with the associated transfer of swissdamed, has resulted in the “going-live” date being deferred to the 2nd half of 2024.

Until that time, the established channels will continue to be used for registration of economic operators and updating of information.

Pilot phase

In June 2023, a pilot phase was undertaken with 17 companies which volunteered to test the ACT module of swissdamed (Release 1.0) for the registration of companies and economic operators. The tests were carried out successfully and the constructive feedback and comments raised some interesting points. This has enabled Swissmedic to make additional improvements to the swissdamed platform.

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.