A new guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies is now available. Belgium now offers a synchronised procedure for combined studies. These are clinical trials involving medicinal products combined with a corresponding performance study or a clinical investigation involving medical devices or in vitro diagnostic medical devices. This Belgian approach aligns the timelines of both submission procedures, making it easier and more efficient for sponsors to submit their applications.A new guidance for sponsorsis now available, containing detailed information on the procedures.
FAMHP (Belgian Medicine Agency) · September 15, 2026
New guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies
Belgium introduces synchronised procedure guidance for combined clinical trials with medicinal products and device performance or clinical investigations.
Published by FAMHP (Belgian Medicine Agency). HealthSignal links to the original document; the summary above is extracted from the source text.