The First Module of the swissdamed Medical Devices Database Launches Online in August
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Swissdamed: The New Medical Devices Database in Switzerland
We are pleased to announce that the first module of the swissdamed medical devices database will be available online starting August 2024. This milestone represents a significant advancement in the regulation and transparency of medical devices in Switzerland.
What is Swissdamed?
Swissdamed is the new database developed by Swissmedic for managing medical devices and economic operators in Switzerland. It was created in response to the lack of access to the European EUDAMED3 database, due to the non-updating of the Mutual Recognition Agreement (MRA) with the European Union.
Since May 26, 2021, Swiss economic operators, including manufacturers, importers, and authorized representatives, have been required to register with Swissmedic to obtain a Swiss Single Registration Number (CHRN).
Change in Current Practice Starting August 6, 2024
August 6, 2024, will mark a significant change in current procedures with the launch of the “Actors” module of swissdamed, which will be available for the registration of economic operators. From this date onwards:
- The registration of economic operators will be conducted exclusively online through the website www.swissdamed.ch.
- PDF forms will no longer be used, streamlining the registration process and reducing administrative errors.
Key Dates
- Until July 26, 2024: Applications for registration, CHRN modifications, and mandate notifications will still be accepted in PDF format.
- From August 6, 2024: Swissdamed will be the only platform for registering economic operators. The email inbox CHRN@swissmedic.ch will be replaced by an online contact form.
How Does This Affect Already Registered Operators?
If you are already registered with Swissmedic and hold a CHRN, your data will be automatically migrated to swissdamed. In early August, you will receive a letter with detailed instructions on the next steps. You will not need to register again, only verify your data once it has been imported into the platform.
Future of Medical Device Registration
Testing and Launch of New Features
In June 2024, Swissmedic invited a group of manufacturers and Unique Device Identifier (UDI) issuing agencies to test the initial device upload options.
For 2025, Swissmedic plans to:
- Launch new modules in swissdamed for the voluntary registration of certain medical devices.
- Eventually make device registration mandatory.
- Enhance transparency and provide a comprehensive overview of the Swiss medical device market.
This development strengthens the regulation and safety of medical devices, aligning Switzerland with international best practices.
Benefits of Swissdamed for Economic Operators
- Greater transparency in operator and device information.
- Streamlined administrative processes through a single digital system.
- Error reduction by eliminating PDF form submissions.
- Improved regulatory compliance tailored to the Swiss market.
Frequently Asked Questions
What happens if I don’t verify my migrated data in swissdamed?
Economic operators will receive instructions to verify their information in August. While re-registration is not required, validation ensures data accuracy and updates.
Is the use of swissdamed mandatory?
Yes, starting August 6, 2024, swissdamed will be the only platform authorized for economic operator registration. In the future, medical device registration will also become mandatory.
Can I continue sending emails to CHRN@swissmedic.ch?
No. As of August 6, 2024, all CHRN-related communications must be conducted exclusively via the swissdamed online contact form.
Conclusion
The launch of swissdamed marks a turning point in the regulation of medical devices in Switzerland. Thanks to this platform, economic operators will be able to manage their registrations more efficiently and transparently. Swissmedic remains committed to protecting public health and creating a modern and accessible regulatory environment.
For more information, visit www.swissdamed.ch.
Info Sources: Homepage (swissmedic.ch)
