Swissmedic will release its own registration database. The reason is that, due to the lapsed Mutual Recognition Agreement with Europe for medical devices and IVDs, Swissmedic no longer has Competent Authority level access to EUDAMED.

In an effort toward the “continuing aim of equivalence between regulations in Switzerland and the EU“, swissmdamed’s Economic Operator and Device Registration modules will be similar to the corresponding EUDAMED modules.

The ‘go-live’ is planned for 2024. It will initially only be available for voluntary use. Once the Medical Device and IVD Ordinances are amended, then swissmadmed will become mandatory. 

For more information, including timelines, please read: Swissdamed Registration Database