New Swissmedic Database for Economic Operators and Devices

The Swissmedic database, swissdamed, is a new platform for the registration of economic operators and medical devices, including In Vitro Diagnostic medical devices, in the Swiss medical device market

Swissmedic Database and Module Launch Dates

The first module of swissdamed went live on August 6, 2024, marking the beginning of a phased rollout. The “Actors” module, which is the first to be released, allows economic operators to register online. Those who had previously registered with Swissmedic have been notified about the next steps. Swissdamed aims to provide comprehensive information about medical devices and the economic operators responsible for them in Switzerland, enhancing transparency for the public and healthcare professionals. The database is structured into two modules: “Actors” and “Devices,” along with a public website. The registration of economic operators is effective immediately, and voluntary registration of certain medical devices will begin over the course of 2025.

To align with EU regulations and reduce the burden on economic operators, swissdamed is designed to resemble the EUDAMED database modules.

The “Devices” module will be launched in stages, starting in 2025 with the ability to register “Regulation Devices” (MDR and IVDR) using XML files in the EUDAMED format. Further releases will complete the Devices module, with mandatory device registration to follow once swissdamed is fully developed and corresponding changes to the MedDO/IvDO are implemented.

For more information, click here: swissdamed – swiss database on medical devices

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