Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is active!
Manufacturers, importers, authorised representatives can now register through the Swissdamed website and obtain the CHRN (Swiss Single Registration Number) to unambiguously identify a specific economic operator, as outlined in our previous article.
CHRN is issued to Swiss manufacturers, importers, authorised representatives, and manufacturers of systems and procedure packs, and they have 3 months to register from the moment the device was placed on the Swiss market.
Economic operators already registered—nearly numbering 3,700—do not need to worry about re-registering. Their data will be migrated seamlessly into the new system, and they will receive detailed instructions about the next steps via a letter sent to their registered contact persons.
As of today, Swissdamed actor module is to be used for applying for a new CHRN, requesting changes to the CHRN and notifications for mandates.
New Swiss database & future developments
To ensure alignment between Swiss and EU regulations and to minimise the effort required from economic operators, Swissdamed has been designed to closely resemble the corresponding modules of the European database, EUDAMED.
The second module of Swissdamed, called ‘’Devices’’ will become gradually operational in 2025. In the beginning, only MDR and IVDR devices will need to be registered to that module by using XML files used for EUDAMED. Device registration will become mandatory only when the database is sufficiently developed and legal texts of MedDo and IvDo have been modified.
All Swissdamed-related documents can be found in our Library of Documents – by clicking on the UK & Switzerland icon.
Do you need support with EU or Swiss compliance? Contact us!
References:
Swissmedic (2024) The first module of the Swissdamed medical devices database is live. Retrieved on 06/08/2024
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