Guide destiné aux promoteurs pour la procédure synchronisée des études combinées CTR–MDR/IVDR

Guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies Belgium offers a synchronised submission procedure for combined studies involving medicinal products and medical devices and/or in vitro diagnostic devices. This Belgian approach aligns the timelines of both submission procedures, making it easier and more efficient for sponsors to submit their applications. …