EU HTA Publication Digest: The Early Experiences of Health Technology Assessment Bodies in the Implementation of the European Union Health Technology Assessment Regulation for High-Risk Medical Devices: A Qualitative Study

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. 

In a recent publication, Alshaikh et al. explored how national HTA bodies across 11 EU Member States are preparing for the implementation of the EU Health Technology Assessment Regulation (HTAR) and the introduction of Joint Clinical Assessments (JCAs) for high-risk medical devices and IVDs. The study identified broad recognition of JCAs as a mechanism to enhance evidence quality and enable work sharing, particularly for smaller HTA systems with limited resources. However, many agencies remain in a preparatory or observational phase. Regulatory uncertainty, timeline misalignment, and concerns about manufacturer readiness emerged as key barriers to effective implementation.

Access the full-text article here.