In Switzerland, research projects investigating the clinical properties of medical devices that are carried out prospectively with humans are deemed to be clinical trials of medical devices. The Human Research Act (HRA) and the Clinical Trials Ordinance (ClinO) define the corresponding requirements. They transpose the provisions of the European medical device directives into Swiss law and define national requirements and procedures.
Clinical trials of medical devices that are not yet CE-marked, not used in accordance with the CE-marked instructions for use or whose use has been banned in Switzerland must be authorised by Swissmedic and the competent ethics committee. These trials are monitored by Swissmedic until completion (category C clinical trials).
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.
An application may be submitted simultaneously to the Cantonal Ethics Committee and to Swissmedic