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“, swissdamed’s Actor and Device Registration modules will be similar to the corresponding EUDAMED modules.

The Medical Device Registration module is expected to be functional sometime in 2025.

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