Medical devices

On March 19, 2025, the Ministry of Labor, Health, Solidarity and Families published the Decree establishing a regulatory framework for the restoration and traceability of medical devices for individual use. It mandates that only certified centers may perform refurbishment, introduces a national registry for tracking restored devices, and links LPPR reimbursement to compliance with restorability criteria (pending further specification of applicable device categories).

In February 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in cardiovascular, endoscopy, pulmonology, and general surgical fields.

On January 30, 2025, the Institute for the Hospital Remuneration System (InEK) published the list of requests for innovation funding (NUB) submitted by hospitals in 2024. The medical technologies of cardiovascular, endoscopy, extracorporeal, gastrointestinal, neuromodulation, peripheral vascular, and other technology groups obtained positive status 1.

In January 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in surgical procedures, ophthalmology, men’s health, and orthopedics.

In November 2024, the HTA body of the Tuscany Regional Healthcare published five rapid HTA reports (four new assessments and one reassessment) of medical devices in the cardiovascular, ophthalmology, ENT, and dermatology areas.

The new framework agreement on the medical devices included in the LPPR was signed on July 2, 2024.

On January 30, 2024, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2023. The medical technologies of cardiovascular, ENT, extracorporeal, gastrointestinal, neuromodulation, and other technology groups obtained positive status 1.

NHS England defined a deadline for applications to the High Cost Device List (HCDL) changes to be implemented in the 2025/26 NHS Payment Scheme. The completed application form should be submitted via email by May 31, 2024.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in November 2023. Seven recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, nephrology and urology, and orthopedic devices, as well as medical aids.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 24192 of November 15, 2023, Tuscany Regional Healthcare published one assessment and one re-assessment of medical devices in the cardiovascular and men's health areas.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, neuromodulation, and orthopedic devices, as well as medical aids.

In October 2023, the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) introduced an updated application procedure for the List of implants and invasive medical devices, including a new application form. The new form is organized according to the PICO (Population-Intervention-Comparator-Outcome) principle.