EATRIS, the European Infrastructure for Translational Medicine, has just announced its participation in the stakeholders’ advisory group in the ‘COMBINE’ project, an initiative aimed at providing clarity and alignment at the interface between clinical trials of investigational medicinal products, performance studies of in vitro diagnostics, and clinical investigations of medical devices.

COMBINE is an initiative led by the European Medicines Agency (EMA) and IDIBELL and Istituto Mario Negri, based in Milan, will serve as an EATRIS Expert Centre, playing a crucial role as part of the stakeholder reference group of the project.

There is an increasing number of inquiries directed to competent authorities regarding the design and submission of clinical trials involving candidate investigational medicinal products and medical devices/in vitro diagnostics. Competent authorities for medical devices have similarly faced analogous questions. Recognising the urgency of addressing these challenges, several stakeholder organisations have reached out to the European Commission, expressing their concerns about the delays in conducting combined studies in the European Union. These delays primarily stem from the complex regulatory interplay among the Clinical Trials Regulation (CTR), the In Vitro Diagnostics Regulation (IVDR), and the Medical Device Regulation (MDR).

Therefore, the ‘COMBINE’ project aims to tackle these challenges head-on. The Medical Device Regulation (MDR), In Vitro Diagnostics Regulation (IVDR), and Clinical Trials Regulation (CTR) each contain specific requirements for the respective individual authorisation processes. While combined studies are essential to ensure that innovative treatments are accessible to patients, the interaction of these procedures has presented a significant challenge. Smoother interplay between these regulations would not only benefit regulatory authorities but also reduce the burden on sponsors and ultimately benefit patients.

In the long-term scope of the project, ‘COMBINE’ seeks to clarify and align the interface between clinical trials of investigational medicinal products, performance studies of in vitro diagnostics, and clinical investigations of medical devices. During the initial analysis phase, the project will focus on understanding the challenges and obstacles hindering the alignment of the three regulatory frameworks (MDR, IVDR, CTR) that intersect in combined studies. ‘COMBINE’ will propose effective solutions to address these issues comprehensively.

Dr. Miguel Angel Souto Mora, IDIBELL Director of the Business Development and Innovation Area, expressed his enthusiasm for participating in this initiative, saying: “The ‘COMBINE’ project represents a vital step forward in enhancing the regulatory landscape. By fostering collaboration and alignment between these critical regulatory frameworks, we can facilitate the development and delivery of innovative treatments to patients more efficiently.”