Clinical trials with medical devices: Expected changes in the legal requirements
The legal requirements for clinical trials with medical devices are changing.
The legal requirements for clinical trials with medical devices are changing. 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 26.5.2021, at the same time as the MDR.
Until the ClinO-MD comes into force, further practical information for applicants will follow on this website.
Further information on the ClinO-MD legislative project and on the adaptation of Swiss legislation to MDR can be found on the FOPH's website.
The "Factsheet containing general information on the HRA and the ethics committees" from 2016 is no longer valid with the inception of the ClinO-MD and will be removed from the website.