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.
On December 17, 2025, the Ministry of Health published two draft HTA reports developed within the National HTA Program for Medical Devices and launched a public consultation. Reports concern continuous glucose monitoring and the treatment of benign prostatic hyperplasia. Comments can be submitted until January 16, 2026.
In December 2025, the National Institute for Health and Care Excellence (NICE) in England updated its manual on technology appraisal and highly specialised technologies. The scope and terminology were clarified, and further details were provided to support the production of technology appraisal and highly specialised technologies on HealthTech (that is, medical devices, diagnostics, digital technologies).
On December 9, 2025, the Department of Health and Social Care launched a consultation on the government’s proposals to give ministers limited powers to direct the National Institute for Health and Care Excellence (NICE) in setting the standard cost-effectiveness threshold. Comments can be submitted online by January 13, 2026.
In November 2025, the HTA body of Tuscany Regional Healthcare published six rapid HTA reports (five new assessments and one reassessment) on medical devices in the cardiovascular, gastroenterology, ophthalmology, dermatology and surgical fields.
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.