COMBINE

Initiative leader: European Commission

Duration: 01/06/2023 – Not determined

The MDR, IVDR and CTR contain requirements for the respective individual authorization for clinical investigation, performance studies or clinical trials processes. Combined studies are commonly conducted and are important to ensure that innovative treatments are available to patients. The interaction of procedures is posing a challenge and smoother interplay between these Regulations would reduce burden on sponsors.

The COMBINE project consists of Phase 1 (analysis and delivering proposed solutions) and Phase 2 (possible development of solutions). The scope of analysis phase is to understand challenges and obstacles on the way to alignment of the three frameworks (MDR, IVDR, CTR) that overlap in combined studies and propose solutions, through an analysis of the challenges at the interface between MDR, IVDR, CTR. This is followed by a mapping of competent authority landscape for the different regulations on MS level and parameters relevant to the CT/PS/CI application processes, and the Mapping of Relevant Activities potentially related to the MDR/IVDR/CTR interface (e.g. poss. update of Q&A on interface IVDR/CTR, development of Q&A on performance studies, etc.). The final step is the proposals for solutions that could address the issues identified, taking into account also the mapping of landscape and ongoing work.

The enrolment of Phase 2 is to be decided in early 2024.

ECRIN's Role in COMBINE

The role of ECRIN in the COMBINE initiative is to represent the academia within the initiative’s stakeholder group.