May 2022: Switzerland Update

An update posted on the SwissMedic portal on May 26, 2022, informs users of the change in legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland.

From 26 May 2022, at the same time as the application of the In Vitro Diagnostics Regulation (IVDR) in the EU, clinical trials with in vitro diagnostic medical devices will be regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).

These new transitional periods in the EU have also been taken into account accordingly in the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO). To avoid jeopardizing a sufficient supply of medical devices to Switzerland, the Federal Council has set lengthy transitional periods – over one year for most devices – for designating the CH-REP.

More information can be found here.