Authorisation applications for category C clinical trials of medical devices
Trial-related issues may be discussed with trial subjects only when Swissmedic and the Cantonal Ethics Committee have authorised the trial on the basis of the current document versions. The authorisation procedure is described in Information Sheet BW510_00_001e_MB.
In accordance with Art. 54 of the Therapeutic Products Act (TPA), during the authorisation procedure Swissmedic checks
- whether the requirements set out in Art. 45 TPA are fulfilled (fulfilment of the Essential Requirements)
- whether the risks associated with the device are duly considered in the clinical trial
- whether the device data are in line with current scientific knowledge and are correctly reproduced in the investigation plan.
Before a study can be authorised by Swissmedic, the following basic requirements must be fulfilled:
- The investigational medical device must have reached a sufficiently advanced stage of development to be suitable for use in humans and must have been released for trial by a responsible person.
- All organisational measures must have been taken.
- Documentation that complies with ClinO requirements must have been prepared on the basis of the European medical device directives and the standard EN ISO 14155.