Roadmap and Guidance on the HTA Regulation

Posted on 12.12.2024

Ahead of the application of the Health Technology Assessment Regulation (HTAR), MedTech Europe is expressing concerns over remaining outstanding questions about the regulation’s added value. MedTech Europe and its members are calling for a clear and comprehensive roadmap addressing existing uncertainties throughout the implementation phase of the HTAR to ensure it contributes to innovation, competitiveness and timely access to novel care.

The roadmap should seek to provide clarity and predictability on processes in the different phases of the JCA, on avenues for multi-stakeholder participation, and on the definitions and the application of the provisions in the implementing acts.

MedTech Europe remains committed to ensuring that Europe’s patients and healthcare systems benefit from the latest technology innovations with a major impact in a timely manner. A clear and comprehensive roadmap can be a key tool to ensure all engaged are equipped for the challenges ahead.

Read the full statement below.