EU HTA

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, D'Oca et al. analyzed current practices in the PICO scoping process used to define the scope of Joint Clinical Assessments under the EU HTA Regulation.

On February 16, 2026, the Member State Coordination Group on HTA (HTACG) released its first annual report, detailing all activities of the group and its subgroups in 2025 within the joint EU-level HTA framework. The framework became fully operational on January 12, 2025, when Regulation (EU) 2021/2282 entered into application, creating a legal basis for Member States' cooperation on joint clinical assessments of medicines and medical devices.

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.

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, Dang et al. reviewed the implementation of Joint Clinical Assessments under the EU HTAR (Regulation 2021/2282), analyzing methodological, regulatory, and stakeholder implications across EU Member States.

In January 2026, the HTA Coordination Group published the report on Emerging Health Technologies identified in 2025 within the framework of the EU Regulation on Health Technology Assessment (HTAR). The report provides information on technologies (including 15 medical devices) that may be eligible for Joint Clinical Assessments (JCAs) at the EU level from 2026.

On January 07, 2026, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment. Requests related to both medical devices and medicines can be submitted until February 04, 2026.

On November 28, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published its annual Work Programme for 2026, outlining the priorities and activities within the joint EU-level HTA framework (EU HTAR). In 2026, HTACG plans to initiate about five joint clinical assessments (JCAs) for medical devices with the first assessments expected to start in June 2026. The Work Programme also sets out the 2026 schedule for Joint Scientific Consultations (JSCs).

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, Severens et al. analyzed Europe-wide perspectives on the implementation of the EU HTA Regulation, mapping key implementation challenges and proposing actions to support a smoother transition.

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, Mezei et al. examined regulatory and methodological barriers affecting digital health technologies, drawing on surveys, interviews, and focus groups with developers from ten European countries.

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, Johns et al. examined the practical implications of the EU Joint Clinical Assessment (JCA) for countries considering cost-effectiveness analyses.

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, Sciattella et al. shared the outcomes of the 2024 Italian Health Policy Forum, which explored how Italy is preparing for the implementation of the EU HTA Regulation 2021/2282.

On October 17, 2025, the European Commission adopted an implementing regulation that sets detailed procedural rules for Joint Clinical Assessments of medical devices and in vitro diagnostics under the HTA Regulation, which entered into force on 12 January 2025.