Clinical investigations with medical devices and other devices specified in Art. 1 MedDO are systematic investigations involving one or more human subjects undertaken to assess the safety or performance of the device (Art. 2 para. 1 let. abis ClinO-MD).
Pre-market clinical investigations
Category C (pre-market) clinical investigations are subdivided into the following sub-categories:
- C1: The medical device is CE-marked but is not used in accordance with the CE-marked instructions for use.
- C2: The medical device is not yet CE-marked.
- C3: The placing on the market, putting into service or use is prohibited in Switzerland.
These "pre-market" investigations must be authorised by Swissmedic and the responsible cantonal ethics committee. Applications for the authorisation of category C clinical investigations and any subsequent submissions in the authorisation procedure must be sent on the same day to Swissmedic and the responsible cantonal ethics committee. Swissmedic can issue an authorisation only if the ethics committee has already approved the same version of the trial documentation.
Post-market clinical investigations
Other investigations with medical devices only require the authorisation of the cantonal ethics committee (category A clinical investigations) and do not need to be submitted to Swissmedic.