August 18, 2023
With the European medical device and IVD regulations Date of Application and the expiration of the agreement on mutual recognition of conformity assessments (MRA) between the EU and Switzerland, Switzerland has been operating as a “third country.”
Even without the MRA, 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 aspects of the EU legislation.
The regulator in Switzerland, Swissmedic, has been posting content to their website related to the Swiss Database on Medical Devices, swissdamed.
Background on Swissdamed in 2022
Swissmedic began to implement swissdamed in April 2022. It consists of two interconnected modules plus a public website. Similar, to the European database, EUDAMED, Swissdamed will track information on medical devices and economic operators. The structure will be similar to the corresponding EUDAMED modules.
At the time, Swissmedic indicated that there would be three releases of Swissdamed: registration of economic operators, registration of medical devices and improvements to those two modules. However, this now appears to have changed.
Release of Swissdamed timeline in August 2023
Swissmedic shared the timing of the modules (update Overview section, August 8, 2023).
- Registration of economic operators (ACT module) - early 2024
- swissdamed – publicly accessible platform - early 2024
- Registration of devices (UDI module) - Summer 2024
Swissdamed pilot in June 2023
Swissmedic indicated that the timing had been verified based on a pilot of the ACT module In June 2023. Seventeen volunteer companies tested the ACT module.
Modules in Swissdamed not mandatory yet
The modules in Swissdamed will only become mandatory when the Swiss legislation, MedDO and IvDO are amended.
Emergo by UL will continue to monitor and provide updates on these developments.
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