Swissmedic
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
Swissmedic
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
Swissmedic
The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
EU
The new article provides comprehensive guidance on the reporting form to be used in the context of performance studies involving in vitro diagnostic medical devices.
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
