In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic introduced a new database: Swissdamed. Swissdamed stands for “Swiss Database on Medical Devices”, implemented to fulfill the obligations of the Swiss legislation on medical devices and IVD medical devices.
Why is Swissdamed necessary?
In 2021, the European Union decided not to update the Mutual Recognition Agreement of conformity assessment (MRA) between the EU and Switzerland. Thus, a separate legislation applies in the two areas. Consequently, this also implies that Switzerland has to have its own database, and EUDAMED, the EU database, cannot be used to register economic operators and devices targeting the Swiss market. Nonetheless, the two database will have similar modules.
Roll out of the new database
In April 2022, Swissmedic began the implementation of Swissdamed, which will consist of two linked modules and a public website. Currently, economic operators register with Swissmedic, as the Swiss database is not available yet. With the registration, they will receive a unique Swiss registration number (CHRN). Once received this number, economic operators will not need to register again on the database.
Swissdamed will be rolled out in three releases:
- Registration of economic operators.
- Registration of medical devices.
- Introduction of additional functions.
Eventually, registration will become compulsory by 2023.
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