EU HTA

On 28 October 2026, the European Commission published a draft implementing act proposing the selection of PRIMA Products for Joint Clinical Assessment (JCA) at the EU level under Regulation (EU) 2021/2282. A second technology, the CEVIRA device for cervical photodynamic therapy, was not selected for JCA. The draft will be discussed at the HTA Committee meeting on 13 November 2026 before the formal adoption process is completed.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, D'Oca et al. explored early national perspectives on the implementation of Joint Clinical Assessments under the EU HTA Regulation.

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, Smela et al. analyzed recommendations for systematic literature reviews within the EU Joint Clinical Assessment framework and compared them with established evidence-based medicine standards.

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, Aballéa et al. critically reviewed the EU HTA Coordination Group guidelines on direct and indirect treatment comparisons in the context of joint clinical assessments.

In July 2026, the French National Authority for Health established MiMED department within its Directorate for Evaluation and Access to Innovation. The new department will modernize health technology assessment methods, strengthen the use of real-world data, and support France's contribution to European HTA coordination.

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, de la Cuadra-Grande et al. developed a methodological framework for interpreting indirect treatment comparisons within the European Joint Clinical Assessment process under the Health Technology Assessment Regulation.

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, Sarri et al. mapped the role of real-world evidence within the EU Health Technology Assessment Regulation, examining its methodological applications in EU joint clinical assessments.

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, Meregaglia et al. explored the expected impact of implementing the EU HTA Regulation and Joint Clinical Assessment through a multi-stakeholder case study in Italy.

On June 3, 2026, the submission period opened for Joint Scientific Consultation (JSC) requests under the EU Health Technology Assessment Regulation (HTAR) framework. The deadline for submitting requests is July 1, 2026. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future EU Joint Clinical Assessment.

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, Xander et al. examined the legal implications of Joint Clinical Assessments under the EU HTA Regulation, focusing on PICO disparities across Member States and conflict-of-interest management in expert involvement.

The EU Health Technology Assessment Regulation (HTAR) framework will host a webinar on June 19, 2026, aimed at providing clarity on the processes for joint clinical assessments (JCA) and joint scientific consultations (JSC) concerning high-risk medical devices and in vitro diagnostics (IVDs). Registration is now open

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, Taylor et al. explored challenges and opportunities associated with incorporating real-world evidence into submissions under the EU’s new Joint Clinical Assessment process.