Medical devices

In July 2026, the French Ministry of Health granted early coverage under the PECAN scheme to a digital medical device (Poppins Clinical) for the rehabilitation of specific learning disorders involving reading deficits. Since the scheme's inception in 2023, all devices granted early coverage have been intended for remote patient monitoring. The decision on Poppins Clinical marks the first PECAN coverage of a therapeutic digital medical device.

In July 2026, the Dutch government allocated €102.5 million to strengthen the national MedTech ecosystem. The initiative responds to the MedTech Growth Plan and aims to address healthcare workforce shortages and rising demand for care by supporting innovation, implementation, and closer cooperation among industry, healthcare providers, and research institutions.

In late March 2026, Norway’s “New Methods” framework announced a revised process for managing medical technologies (i.e., medical devices, in-vitro diagnostics, procedures), effective May 1, 2026. The update introduces new entry pathways, application process, prioritization criteria, and procedural changes such as early assessment and implementation meetings. Medical device companies are invited to a digital information session on April 17, 2026, with registration required by April 14, 2026.

On January 30, 2026, the Institute for the Hospital Remuneration System (InEK) published the list of innovation funding (NUB) requests submitted by hospitals in 2025. The medical technologies of cardiovascular, endoscopy, extracorporeal, gastrointestinal, neuromodulation, peripheral vascular, and other technology groups obtained a positive status 1.

In January 2026, Italy entered the operational phase of the 2026–2028 National Health Technology Assessment Program for Medical Devices (PNHTA-DM) following the release of approximately €13 million from the national medical device governance fund. Coordinated by the National Agency for Regional Health Services (AGENAS), the program strengthens Italy’s national HTA system that will impact market access and procurement decisions for medical technologies.

On January 1, 2026, the specifications of the call for projects "Support for disruptive innovations in the implantable medical devices and surgical robotics sector" were approved. This initiative, part of the France 2030 investment plan, aims to support research and development projects targeting implantable medical devices and next-generation surgical robots.

On December 19, 2025, an order was issued registering the Symplicity Spyral renal denervation catheter in Title V of the List of Reimbursable Products and Services (LPPR), enabling add-on reimbursement for medical devices used in hospital settings. The Symplicity Spyral received a positive opinion for LPPR registration in December 2023, following transitional coverage under the French innovative payment scheme known as pre-LPPR since December 2022.

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.