Health technology assessment

In October 2025, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched two new thematic horizon scans focusing on cancer care. The scans aim to identify innovative medical technologies that may be evaluated within the national Orderly introduction framework for medical technologies. Stakeholders, including industry representatives, are invited to submit proposals by November 30, 2025.

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 14, 2025, it was announced that the decree from the Ministry of Health for the National HTA Program for Medical Devices (PNHTA-DM) 2026–2028 has been submitted to the State–Regions Conference opinion. The Program was developed by the National Agency for Regional Health Services (AGENAS) and approved by the HTA Steering Committee.

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.

On October 14, 2025, the National Agency for Regional Health Services (AGENAS) published the list of technologies prioritized for evaluation within the National HTA Program for Medical Devices in 2025. Technologies from the fields of endocrinology, men’s health, neurology/neurosurgery, and radiotherapy have been identified as priorities and are currently undergoing health technology assessment.

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.

On September 10, 2025, the French National Authority for Health (HAS) published its evaluation principles for the reimbursement of digital medical devices via the list of medical telemonitoring activities (LATM) and advanced reimbursement for therapeutic and telemonitoring digital medical devices (PECAN). The HAS has also updated evaluation principles for reimbursement of medical devices for individual use via the List of Reimbursable Products and Services (LPPR), Intra-DRG (Intra-GHS) List, and transitional support (PECT).

In July 2025, the HTA body of Tuscany Regional Healthcare published nine rapid HTA reports (eight new assessments and one reassessment) of medical devices in the ENT, neurosurgery, ophthalmology, orthopedics, peripheral vascular, and surgical procedures fields.

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.

At the end of July 2025, the Ministry of Health published the first report within the national HTA program for medical devices. The program was established in 2017; however, it became fully functional only in late 2023, and the first assessment was launched in 2024 concerning robotic surgery in general (gastrointestinal) surgery, gynecology, and urology areas.

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.