The First Module of the swissdamed Medical Devices Database Launches Online in August
We are pleased to announce that the first module of the swissdamed medical devices database will be available online starting August 2024. This significant milestone represents a major advancement for the regulation and transparency of medical devices in Switzerland.
Since the Mutual Recognition Agreement (MRA) with the European Union has not been updated, Swissmedic has lacked access to the European database EUDAMED3. As a result, 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 change in current practice with the launch of the Actors module of swissdamed, which will be available for the registration of economic operators. From this date onward, the registration process will be exclusively conducted online through the website www.swissdamed.ch, eliminating the need for PDF forms.
Key Dates
- Until July 26, 2024: Applications for registration and changes to CHRN, as well as mandate notifications, will be accepted in PDF format until this date.
- From August 6, 2024: The swissdamed platform will be used exclusively for the registration of economic operators, replacing the email inbox CHRN@swissmedic.ch with an online contact form.
What Does This Mean for Already Registered Operators? Data for approximately 3,700 economic operators who are already registered with Swissmedic and have a CHRN will be automatically migrated to the new system. In early August, these operators will receive a letter with detailed instructions on the next steps. They will not need to register again; they only need to verify their data once it has been imported into swissdamed.
Future of Device Registration In June 2024, a group of manufacturers and agencies issuing Unique Device Identifiers (UDIs) were invited to test initial device upload options. In 2025, Swissmedic plans to launch additional sections of swissdamed for the voluntary registration of certain devices, with intentions to make this registration mandatory in the future. This advancement will improve transparency and provide an overview of the range of devices available in the Swiss market.
This development marks a crucial step towards enhancing the regulation and safety of medical devices in Switzerland. Swissmedic remains committed to protecting public health and facilitating an efficient and transparent regulatory environment.
Info Sources: Homepage (swissmedic.ch)
