HTA

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.

On October 6, 2025, the European Digital Health Technology Assessment (EDiHTA) framework announced the publication of its first scientific paper on stakeholder perspectives in digital health assessment. Furthermore, digital health innovators are invited to complete a short survey to inform development of the EDiHTA toolkit.

As of October 2025, the Swedish Dental and Pharmaceutical Benefits Agency is working on health technology assessments in several areas, including endocrine, e-health, and neurology procedures.

As of September 2025, the Swedish Agency for Health Technology Assessment and Assessment of Social Services is working on health technology assessments in several areas, including in-vitro diagnostics, e-health, and gynecology procedures.

In August 2025, the National Institute for Health and Care Excellence (NICE) announced two new projects within its Health Technology Assessment Innovation Laboratory (HTA Lab). The projects explore generative AI technologies in economic modelling and how AI can support and enhance NICE’s HTA processes through automation, predictive modeling, and reasoning systems.

As of August 2025, the Centre for Assessment of Medical Technology in Örebro region in Sweden is working on health technology assessments in several areas, including in-vitro diagnostics, neuromodulation, and orthopedics.

As of August 2025, the Scottish Health Technology Group is developing four Med Tech-related HTAs in cardiovascular, diagnostic imaging, neurology and neurosurgery, neuromodulation, and orthopedics areas.

On July 14, 2025, NICE published a HealthTech program manual. A new program will combine the former Medical Technologies Evaluation and Diagnostic Assessment programs and the Interventional Procedures program. The HealthTech program will produce two types of guidance: HealthTech guidance for devices, diagnostics, and digital products, and Interventional Procedures guidance. A life-cycle approach will be utilized for assessment and recommendations: early use, routine use, and existing use (late stage assessment).

In June 2025, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including diagnostic imaging, e-health, in-vitro diagnostics, men’s health and neurology.

On June 2, 2025, 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 (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

On May 5, 2025, the Belgian Health Care Knowledge Centre (KCE) opened its annual call for topic proposals for the 2026 research program, which includes Clinical Guidelines, Health Technology Assessments, and Health Services Research. Interested stakeholders can submit the proposals by June 30, 2025.

In the first quarter of 2025, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published two health technology assessments in the robotic surgery field and proceeded with working on HTAs in the e-health, endocrine, and neurosurgery fields.