Health technology assessment

On May 20, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the MHRA-NICE Real-World Evidence Scientific Dialogue (RWE SD) pilot has become an established service. The service will be delivered through precompetitive “safe harbour” workshops jointly convened by the MHRA and the National Institute for Health and Care Excellence (NICE). Four workshops will be held each year, organized across two application cycles. Expressions of interest for the first 2026 cycle may be submitted until August 17, 2026.

In May 2026, Spain approved its first state framework for health technology assessment (HTA) in the National Health System. Royal Decree 415/2026 establishes the rules for HTA activities used to support decisions on the incorporation, financing, pricing, reimbursement, modification of use conditions, or disinvestment of health technologies. The framework will enter into force 20 days after publication of the Decree, followed by phased implementation.

On April 22, 2026, NICE published an updated NICE-wide Topic Prioritisation manual (PMG46) for consultation to include further details on how NICE will prioritize topics for evaluation. The deadline for comment submission is May 19, 2026.

In April 2026, the Danish Healthcare Quality Institute (DHQI) released its first Method and Process Guide for Health Technology Assessment (HTA). The guide outlines both the methodological framework for HTA and the overall process, covering topic selection, assessment, and the DHQI Council's recommendations to regions on the implementation of treatment methods (e.g., medical technologies and procedures).

In April 2026, the HTA body of Tuscany Regional Healthcare released six rapid HTA reports (four new assessments and two reassessments) on medical devices in the cardiovascular, neurovascular, and dermatology fields.

On April 1, 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 April 29, 2026.

On March 20, 2026, the Danish Healthcare Quality Institute (DHQI) opened a call for submissions of clinical issues for health technology assessment (analysis or evaluation). Proposals from healthcare stakeholders will undergo validation and prioritization, with selected topics taken forward for evaluation and the development of national recommendations.

In March 2026, the HTA body of Tuscany Regional Healthcare released four rapid HTA reports (three new assessments and one reassessment) on medical devices in the cardiovascular, peripheral vascular, interventional radiology, and orthopedics fields.

In January 2026, the HTA body of Tuscany Regional Healthcare published two rapid HTA reports (one new assessment and one reassessment) on medical devices in the cardiovascular and surgical fields.

In January 2026, Italy entered the operational phase of the 2026–2028 National Health Technology Assessment Program for Medical Devices (PNHTA-DM) following the release of approximately €13 million from the national medical device governance fund. Coordinated by the National Agency for Regional Health Services (AGENAS), the program strengthens Italy’s national HTA system that will impact market access and procurement decisions for medical technologies.

In December 2025, the HTA body of Tuscany Regional Healthcare published seven new rapid HTA reports on medical devices in cardiovascular, neurosurgery, neuromodulation, orthopedics, urology, and surgical fields.

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.