Medical devices

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.

The so-called hybrid DRGs reimbursement mechanism will first cover services from the “starting catalog”, and it will be implemented at the beginning of 2024. The catalog itself is still not publicly available.

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 September 2023. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern, peripheral vascular and neurovascular, neurology and neurosurgery, ENT, spine, ophthalmology, and orthopedic devices, as well as medical aids.

On September 1, 2023, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process for the innovation funding of the new examination and treatment methods (NUB) for 2024. The Federal Joint Committee (G-BA) reminds applying hospitals about minor changes in application requirements.

On September 5, 2023, the Ministry of Health published the Decree of June 9, 2023, on the adoption of the 2023-2025 National HTA Medical Devices Program.

On September 19, 2023, the Innovative Devices Access Pathway (IDAP) pilot was launched. IDAP program aimed to accelerate the development of cost-effective medical devices and their integration into the UK market. The application window to join the pilot phase is now open to the UK and international commercial and non-commercial developers of innovative health technology. The deadline is October 29, 2023. Eight products will be selected for the pilot phase and receive non-financial support from a team of experts.