Medical devices

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 September 8, 2025, the FPS Public Health opened the “Reducing Single-Use in Hospitals (ReSUH)” call, inviting accredited general, psychiatric, and university hospitals to implement concrete measures to reduce single-use medical products within a broader sustainability strategy.

On September 1, 2025, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process according to §6 (2) KHEntgG (New Examination and Treatment Methods, NUB) for 2026.

On September 6, 2025, the specifications of the call for projects "Third places for MedTech experimentation" were approved. This initiative is part of the France 2030 investment plan and aims to fund the creation of collaborative testing hubs within healthcare facilities to accelerate the development and market access of innovative medical devices, with a specific focus on surgical robotics and implantable medical devices.

On September 6, 2025, the Ministry of Labor, Health, Solidarity and Families authorized a two-year experiment on the reprocessing of certain single-use medical devices used in the cardiology field, including cardiac electrophysiology and mapping, cardiac ablation, angiography devices, and ultrasound catheters. The experiment aims to assess the technical feasibility, safety, economic impact, and environmental benefits of this practice, with a view to its permanent establishment and expansion. The experiment will start on January 1, 2026.

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.