Abstract

The European Commission’s COMBINE ‘all-in-one’ pilot  offers an opportunity for the coordinated assessment of combined studies in EEA countries, where the Clinical Trials Regulation (CTR), the In Vitro Diagnostic Medical Devices Regulation (IVDR) and the Medical Devices Regulation (MDR) interplay.

Drawing on first-hand sponsor experience from two successfully approved pilot combined studies, this article demonstrates how aligned submissions and coordinated parallel assessments provide a smoother, more predictable approval process with reduced complexity, ultimately fostering faster patient access.

Finally, it outlines key operational challenges during submission preparation and Request for Information (RFI) management, offering scalable sponsor solutions and policy recommendations to further improve efficiency.