Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
Recent news and posts
Experiment on the reprocessing of single-use medical devices authorized in France
On September 6, 2025, the Ministry of Labor, Health, Solidarity and Families published a Decree in the Official Journal of the French Republic authorizing a two-year experiment on the reprocessing of certain single-use medical devices. The experiment aims to assess the technical feasibility, safety, economic impact, and environmental benefits of reprocessing certain single-use medical devices and to define, in this case, the legal and technical framework required to guarantee patient safety and treatment efficacy, with a view to potential permanent establishment and expansion of this practice.
The Decree defines two reprocessing circuits:
- Open: Medical devices are reprocessed and recertified with the "CE" mark by a natural or legal person deemed to be the manufacturer;
- Closed: Medical devices are reprocessed by an external reprocessing company at the request of the healthcare establishment and must be returned to that original hospital.
Participation for hospitals and reprocessors is subject to a formal process via a call for applications.
Reprocessing should be carried out according to a process defined in the Annex to the Decree, including several steps, such as pretreatment, cleaning, sterilization, and functional testing.
The devices concerned are listed in the Annex to the Decree and include cardiac electrophysiology and mapping devices, cardiac ablation devices, angiography devices, and cardiac and coronary ultrasound catheters.
The experiment will start on January 1, 2026.
See full details in French here.
This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.