Being at the vanguard of regulatory intelligence and testing, also when it comes to the complex landscape of medical devices is key for Complife.

For this reason, today we want to share an update on a critical initiative that’s set to revolutionize how innovative combined treatments gain approval in the European Union: the COMBINE project.

 

The journey for the COMBINE project began in June 2023, when the European Commission and Member States’ competent authorities joined forces to tackle the intricate challenges faced by sponsors developing “combined studies”—those involving the parallel application of regulations for medicinal products (Clinical Trials Regulation – CTR), medical devices (Medical Device Regulation – MDR), and in vitro diagnostics (In Vitro Diagnostic Regulation – IVDR). These are the truly innovative treatments that blend pharmaceuticals with cutting-edge devices or diagnostics.

 

The initial phase, completed in May 2024, involved an analysis of the root causes of these regulatory complexities. This led to a comprehensive report outlining proposed solutions. Building on this foundation, the second phase, endorsed by Member States in December 2024, launched a program of several projects designed to implement these solutions.

 

The focus today is on COMBINE Project 1 Pilot, which kicked off in June 2025. This pilot it’s designed to streamline the authorization process for multinational combined studies by synchronizing the parallel reviews conducted by national competent authorities and ethics committees. The goal? To facilitate simultaneous submission, validation, and assessment, ultimately aligning the timing of required authorizations.

 

The COMBINE Project 1 Pilot is currently accepting expressions of interest for studies planned for submission between September 2025 and March 2026.

 

What are the key advantages for companies looking to conduct combined studies under this pilot?

– Synchronized Review Process: Goodbye to fragmented submissions and reviews. This pilot aims for a single, coordinated process, integrating both the clinical trial (under CTR) and the medical device/IVD performance study (under MDR/IVDR) aspects.

– Reduced Administrative Burden: By streamlining submissions and assessments, the pilot seeks to significantly lessen the administrative load on sponsors, allowing you to focus more on the science and less on paperwork.

– Harmonized Approach: This project fosters greater consistency across EU Member States for combined studies, reducing potential discrepancies and complexities in multinational trials.

This pilot phase is crucial for refining the integrated process and gathering real-world insights.

 

What’s Next for the COMBINE Project?

Specific timelines for the pilot’s full integration into standard practice will depend on the outcomes and lessons learned from these initial studies, nevertheless the clear direction is towards a more permanent and simplified approval pathway for combined products.

Our team is closely monitoring the evolution of the COMBINE project and is ready to support your organization in navigating these new pathways.

To know more read the full document

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