Performance studies with IVD

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:

The Information sheet BW600_00_16e_MB contains a decision tree* to help you determine whether your research project must be submitted to Swissmedic. Performance studies that have to be submitted to Swissmedic according to the decision tree also need to be authorised by Swissmedic and the responsible cantonal ethics committee. Applications for the authorisation of category C performance studies 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.


*Decision tree for categorization of performance studies

Entscheidbaum zur Kategorisierung von Leistungsstudien
Permanent link of this page