Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD medical devices marketed in their territory – to an online portal to increase the transparency and traceability of the devices. Similar to EU EUDAMED, Switzerland started developing Swissdamed, the “Swiss Database on Medical Devices”. Swiss manufacturers and other stakeholders need to stay informed about the related regulatory updates, as the registration will become mandatory when the Medical Devices Ordinance and IVD Medical Devices Ordinance will be amended to include the Swissdamed registration obligation. In the meanwhile, Swiss economic operators have to register with Swissmedic.
Roll-out and pilot phases
In June 2023, 17 companies took part to the Swissdamed pilot phase. The pilot phase successfully tested the first module of the database to register companies and economic operators. The platform is believed to go live in second half of 2024 (Update: April 2024).
The structure of Swissdamed will consist of two modules accessible only to registered users, while a free search function will be available to all users in early 2024. The two modules are:
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- ACT module for the registration of companies and economic operators –> 2nd half of 2024 (originally, early 2024)
- UDI module for the registration of devices –> 4 months after the ACT module goes live (originally, from summer 2024)
Planning in August 2023:
(Source Swissmedic 2023)
Planning in April 2024:
(Source Swissmedic 2024)
Swissdamed registration obligation for economic operators and medical devices
The registration as an actor allows economic operators to receive their CHRN, the Swiss Single Registration Number. Once their devices are placed on the market, Swiss economic operators have up to three months to register.
The CHRN is a unique number that permits the identification of the economic operator. Currently, economic operators receive their CHRN when registering with Swissmedic, while from 2024 the identification number should be assigned by Swissdamed. Economic operators that are now registering with Swissmedic and receives their CHRN do not have to register again in Swissdamed once the database is functional. According to the Swiss Ordinances on medical devices, the economic operators that are required to have the CHRN are Swiss manufacturers, authorised representative, and importers. Non-Swiss manufacturers do not have to register and do not have to be assigned a CHRN. However, non-Swiss manufacturers must appoint an authorised representative based in Switzerland that is registered with Swissmedic and has a CHRN.
References:
Swissmedic (2023) Registering economic operators (CHRN). Retrieved on 17/08/2023.
Swissmedic (2023) swissdamed – Swiss Database on Medical Devices. Retrieved on 17/08/2023.
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