Go Live for the Swiss Medical Devices Database 'Swissdamed'
2 August 2024
Switzerland is launching the first module of its medical device database swissdamed. Created by the Swiss authority Swissmedic, the database for the enforcement of the medical devices and in vitro diagnostic regulation is based on two modules which will be released gradually starting with Module 1 going live on 6 August 2024 and dealing with the registration of companies and economic operators that are not yet registered. Module 2 for the product registration will be available from 2025, initially on a voluntary basis.
Swissmedic currently does not have access to EUDAMED because the mutual recognition agreement between the European Union and Switzerland has not yet been updated.
For the actors, the registration process is basically not new. From 26 May 2021, Swiss manufacturers, importers and authorised representatives must register with swissmedic to receive a CHRN, Swiss Single Registration Number. The introduction of swissdamed, however, will bring few changes in the registration process and CHRN change procedure. Previously this was done using a PDF form, but from 6 August on this will only be possible via the swissdamed application. Companies and economic operators that are already registered and also have a CHRN number do not have to re-register. Their data will all be migrated. They only need to check the transferred data in swissdamed. For further information please view the Swissmedic release note.
