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.
The procedure applies to most national and multinational combined studies for which authorisation is required under both the Clinical Trials Regulation (CTR) and the Belgian procedure for a consolidated opinion on medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
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Guidance for sponsors