Legal Framework Establishes the Foundation
Decree No. 2025-895 defines the legal framework for the national pilot phase and aligns it with the European Medical Device Regulation (MDR) (EU) 2017/745 and the Implementing Regulation (EU) 2020/1207.
Reprocessing (remanufacturing) is permitted under two models: CE reprocessing and CS reprocessing.
In CE reprocessing, the reprocessor is legally considered the manufacturer.
In CS reprocessing, the process is carried out by an external service provider on behalf of a healthcare institution, and the reprocessed products are returned exclusively to that institution.
Two-Year Trial Begins in 2026
The pilot phase will start on 1 January 2026 and run for two years.
A steering committee—comprising representatives from the Ministry of Health, participating institutions, manufacturers, and reprocessing companies—will oversee its implementation.
In parallel, an independent evaluation committee will assess the economic and environmental impacts, the level of acceptance among healthcare professionals and patients, and the organisational implications.
The selected categories initially include medical devices for electrophysiology.
After two years, a final report will provide the basis for a political decision on whether to extend, generalise, or conclude the pilot phase.
Benefits: Economy, Environment, Europe
With this decision, France expands the scope of action for hospitals and reprocessors.
Reprocessed products can lower costs, reduce waste and CO₂ emissions, and strengthen economic, ecological, and supply chain resilience within the healthcare system.
France thus follows the example of ten other EU countries, including the United Kingdom, that have already incorporated such measures into national law.
Sources:
Légifrance: Décret n° 2025-895 du 4 septembre 2025, Journal officiel
