Bern, Switzerland – August 6, 2024
Swissmedic has announced the successful go-live of the Swissdamed Actors Module today. This marks a significant milestone in the regulatory framework for medical devices in Switzerland, streamlining the registration process for economic operators, including manufacturers, importers, and authorized representatives.
Starting today, all registrations must be completed through the Swissdamed platform. This change means that the previous practice of submitting PDF forms for the Swiss Single Registration Number (CHRN) is now obsolete. The Swissdamed system will provide a more efficient and secure method for managing registrations, ensuring compliance with Swiss and EU standards.
Key Changes and Benefits
- Seamless Data Migration: Nearly 3,700 economic operators who were previously registered with Swissmedic will have their data migrated to the new system. These operators will receive instructions on verifying their data via letters sent to their registered contacts
- Enhanced Regulatory Compliance: The Actors Module is designed to mirror the functionality of the European EUDAMED database, facilitating easier compliance for companies operating across both jurisdictions. This alignment aims to reduce the administrative burden and enhance data accuracy
- Future Developments: The next phase of Swissdamed includes the Device Registration Module, expected to become operational in 2025. Initially, device registration will be voluntary, with mandatory registration following as the system develops and relevant legal adjustments are made
Economic operators who have not yet registered must now use the Swissdamed platform for all new registrations, changes to CHRNs, and mandate notifications. Swissmedic has provided detailed guidance and support to ensure a smooth transition for all stakeholders involved
Support from Europe IT Consulting GmbH
Europe IT Consulting GmbH, which is also registered in the Swissdamed system, will offer support to clients with UDI data transmission once the Device Registration Module goes live. Our team is prepared to assist with the transition and ensure compliance with the new regulatory requirements.
For more information and to access the Swissdamed registration system, visit Swissdamed.
If you interested in how to prepare for Swissdamed you can contact us.
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