Announcements on clinical trials with medical devices and performance studies with in vitro diagnostic medical devices
13 avril 2023 – Swissmedic has updated the guidance for the submission of combined trials, and for submissions for already authorised trials that are newly becoming combined trials.
The corresponding information can be found in Annex A7 of the Swissmedic information sheets BW600_00_015e_MB (for combined trials of medicinal products and medical devices) and BW600_00_016e_MB (for combined trials of medicinal products and companion diagnostics / IVDs).
For more information, see here.