In Switzerland, research projects involving one or more human subjects, undertaken to systematically assess the safety or performance of medical devices are deemed to be clinical trials of medical devices. The Human Research Act (HRA) and Ordinance on Clinical Trials with Medical Devices (ClinO-MD) define the corresponding requirements for clinical trials with medical devices and devices without a medical purpose listed in Article 1 of the Medical Devices Ordinance (MedDO). They transpose the provisions of the European medical device regulation into Swiss law and define national requirements and procedures.
Clinical trials fall under category C if the medical device carries a CE-mark but will not be used in accordance with the CE-marked instructions for use (off-label use, Category C1), or is not CE-marked (C2), or when its placing on the market or use is prohibited in Switzerland (C3). These “pre-market” trials require the authorization of Swissmedic and the cantonal ethics committee. Applications for authorisation must be sent on the same day to the ethics committee (BASEC portal) and Swissmedic (eMessage portal).
Other trials with medical devices only require the authorisation of the cantonal ethics committee (category A clinical trials) and do not need to be submitted to Swissmedic.
Clinical trials with in-vitro diagnostic medical devices are still regulated by the Clinical Trials Ordinance (ClinO). They will be included in the ClinO-MD at the same time as the planned date of application of the EU regulation on in vitro diagnostic medical devices (May 26, 2022).