Decree on restoration of medical devices for individual use in France

On March 19, 2025, the Ministry of Labor, Health, Solidarity and Families published the Decree in the Official Journal of the French Republic, establishing rules for the restoration and traceability of certain medical devices for individual use. The Decree provides the definition of "restoration to usable condition", specifies that restoration can only be performed in approved centers, and creates the "Registry relating to the official circulation of medical devices" (Enregistrement relatif à la circulation officielle des dispositifs médicaux) to track all reconditioned medical devices for individual use.

Only certified centers and professionals meeting specific accreditation standards may perform restoration operations, maintaining the device's original performance and safety characteristics while assigning a new usage duration that cannot exceed the manufacturer's original lifespan specifications. Providers must inform patients when restored devices are available. For specific devices, reimbursement may require patients to commit to returning the device after use, with this obligation recorded in the registry.

The Decree also refines reimbursement rules under the LPPR by linking eligibility to refurbishment feasibility. It applies specifically to individual-use medical devices falling under Article L. 5212-1-1 of the Public Health Code, which authorities have deemed restorable and reusable under strict safety and quality standards. A new rule added to Article R. 165-4 of the Social Security Code states that if a device on this list has design characteristics preventing safe restoration, it can be deemed ineligible for LPPR reimbursement.

The categories of medical devices subject to restoration will be defined in a separate Order.

Decree entered into force on March 20, 2025.

See the full details in French here.

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