Switzerland Update: Swissmedic Medical Device Database Release Delay

By Razel Cada, Karen Hill, and Evangeline Loh

Aspects of the Swiss medical device regulatory system (Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219)) leverage compliance with aspects of the EU legislation.

As we at Emergo by UL have previously shared (August 2023), the regulator in Switzerland, Swissmedic, has been regularly posting content related to the development of the Swiss Database on Medical Devices, swissdamed: ACT module (registration of economic operators),  publicly accessible platform and UDI module (registration of devices).

In September 2023, Swissmedic released results from a survey performed in the Spring of 2023 on swissdamed. Swissmedic analyzed the responses from 451 responders and published a report (posted to the swissdamed website).   

Release of more detailed swissdamed timeline in February 2024

Swissmedic shared details about the explicit timing of the modules, with the “go-live” date being deferred to the second half of 2024.

Planned releases:

• Registration of economic operators (ACT module) – second half of 2024
• swissdamed – publicly accessible platform – second half of 2024
• Registration of devices (UDI module) – four months after the ACT module is released

There appear to be slight delays from the timeline previously proposed. It was expected that ACT module and Onboarding Actors would start Q1 2024 though this is now expected in the second half of the year. This also delays the UDI module, which will be released as a Minimum Viable Product (MVP), four months after the ACT module goes live. This will allow early adopters of the MVP UDI module to provide feedback to help Swissmedic with improvements/enhancements to swissdamed.

Concluding remarks

The development of medical device databases proves to require more time than expected. While swissdamed is a smaller version of the European database, EUDAMED, there are expected delays to swissdamed as well.

The modules in swissdamed will only become mandatory when the Swiss legislation, MedDO and IvDO are amended. Until then, the registration of economic operators as well as notification of medical devices/IVDs should still be done through the existing systems.

Emergo by UL will continue to monitor and update you on these developments.