Performance study-related contacts with participants may take place only after the performance study has been approved by Swissmedic. The approval procedure is described in information sheet BW600_00_016e_MB.
Before a study can be approved by Swissmedic, the following basic requirements must be fulfilled:
- The device to be investigated must have reached a sufficiently advanced stage of development to be suitable for use in humans and must have been released for the study by a responsible person.
- All organisational measures must have been taken.
- Documentation specified in ClinO-MD must be prepared in accordance with the European Regulation on in vitro diagnostic medical devices. Please observe standard ISO 20916 in relation to the study planning and preparation of the documentation.