In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new "Medical Device Regulation" (ClinO-MD) will come into force on 26. May 2021, at the same time as the MDR. Applications and subsequent applications for clinical trials involving medical devices have to be submitted to both Swissmedic and the competent Cantonal ethics committee on the same day. From 26 May 2021 onwards, Swissmedic will only approve trials for which the same version of the trial documentation has been approved by the ethics committee.