DIA Europe 2024

This session will present the COMBINE project on the interface between the EU regulations on clinical trials, in vitro diagnostics and medical devices. Combined studies can be understood as studies that involve the simultaneous investigation of a medicinal product, an IVD and/or medical device. The COMBINE project aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions to these challenges. The project involves representatives of competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency, and relevant stakeholders from both the medicinal product and the medical device sectors. This is a first of kind collaboration across the clinical trials and medical devices sectors looking into the challenges faced by sponsors and authorities in the assessment and authorisation of combined studies.