Clinical trials

​HM5/MD1/IVD1: Programme COMBINE – Accelerating clinical trials and medical innovation in the EU

By 2025-11-13T12:50:00

Margareth Jorvid

Key points: 

  • The European Commission and EU member states have launched the COMBINE initiative to look at the interplay between the In Vitro Diagnostic Regulation (IVDR), the Medical Device Regulation (MDR) and the Clinical Trials Regulation (CTR), which has been identified as one of the most important issues by stakeholders in the ACT-EU workplan 2025-26 
  • The primary aim of COMBINE is to propose immediate solutions within the existing legal frameworks to overcome the challenges with application procedures and conduct of combined clinical trials of drugs using a device, by moving towards:  
    • One single coordinating member state and an ‘all-in one’ coordinated assessment of clinical trial and performance study (PS) applications 
    • Simplification/harmonisation of PS requirements and review 

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