30 March 2026
Swissmedic: Mandatory Registration of In Vitro Diagnostic Devices in swissdamed from July 2026
From 1 July 2026, registration of in vitro diagnostic devices (IVDs) in the swissdamed system will be mandatory, replacing the previous notification requirement. A transition period applies until 31 December 2026. However, notification remains necessary for repackaged, relabelled, and in-house IVDs as specified by the Ordinance on In Vitro Diagnostic Medical Devices (IvDV). The specific reporting obligations and required documents depend on the IVD category and the type of activity.
For more information, see here.
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