New rules for performance studies
For all performance studies, with the exception of the performance studies listed in Art. 2a para. 1-3 ClinO-MD, the provisions of ClinO-MD apply as of 26 May 2022.
Please refer to the Swissmedic information sheet on interventional performance studies: BW600_00_016e_MB.
Information from the Federal Office of Public Health regarding the transition from the current to the new rules can be found here: