[HEALTH PRODUCTS INDUSTRIES] The contributions of decree no. 2025-895 of September 4, 2025 relating to the experimentation of the reprocessing of certain single-use medical devices

Starting January 1, 2026, France will experiment with the reprocessing of certain single-use medical devices (hereinafter “SUDs”) for two years.

I. An experiment following the lead of other EU Member States, pursuing an environmental objective

European framework for the reprocessing of SUDs

This possibility is governed by Article 17 of Regulation (EU) 2017/745 of April 5, 2017 on medical devices (hereinafter the “MD Regulation”), which grants Member States the choice of authorizing or prohibiting the reprocessing of SUDs, while specifying the reprocessing procedures when authorized.

Reprocessing of SUDs is defined in Article 2(39) of the Medical Devices Regulation as “the process to which a used device is subjected to enable its safe reuse, including cleaning, disinfection, sterilization, and related procedures, as well as testing the used device and restoring its technical and functional safety characteristics.” It should not be confused with the sterilization process applicable to multiple-use medical devices or with the restoration of certain medical devices for individual use to a suitable state for use.

Implementing Regulation (EU) 2020/1207 of 19 August 2020 establishes common specifications for reprocessing.

As of January 2025, only about a third of Member States authorized the reprocessing of SUDs (Belgium, Croatia, Germany, Iceland, Ireland, Poland, Portugal, the Netherlands, Spain, and Sweden).

France’s Experimental Approach

In France, the reprocessing of DMUUs is prohibited, as stated in Article L. 5211-3-2 of the French Public Health Code (hereinafter “CSP”). However, with the aim of reducing the ecological footprint of healthcare products, Article 66 of the Social Security Financing Act for 2024 (hereinafter “LFSS for 2024”) provides for a two-year, exceptional experiment in the reprocessing of DMUUs.

Under the experiment, reprocessing may not be carried out directly by the healthcare facilities that use them. Facilities may only use reprocessed DMUUs if they have been:

purchased on the market; or
reprocessed, on their behalf, by an external reprocessing company.
Article 66 of the LFSS for 2024 provides that healthcare facilities participating in the experiment will be designated by order of the Minister of Health. The impact study of the 2024 Health Insurance Act envisages the participation of four healthcare institutions.

The Medical Devices Regulation provides that Member States shall encourage, and may require, healthcare institutions to provide patients with information on the use of reprocessed SUDs. Article 66 of the 2024 Health Insurance Act therefore provides for an obligation to provide patients with prior information regarding the use of a reprocessed SUD, as well as a patient’s right to object.

II. Clarifications provided by decree

The contributions of Decree No. 2025-895 of September 4, 2025, published in the Official Journal of the French Republic No. 0207 of September 6, 2025

The purpose of this decree is, in particular, to list the categories and types of SUDs that may be reprocessed. Thus, only UMDs related to certain categories of electrophysiology and cardiac mapping, cardiac ablation, or angiography and hemodynamic devices are targeted by the experiment.

A decree will specify the content of the written document that the institution requires the patient to sign, on which the patient can express their opposition to the use.

In accordance with the terms and conditions set out in the Medical Device Regulation, the decree provides for two reprocessing pathways:

in the so-called “open” circuit, when the medical device has been reprocessed and recertified “CE” by a natural or legal person deemed to be a manufacturer – in this case, the healthcare institution, on the one hand, sells UMDs to be reprocessed and, on the other hand, acquires reprocessed UMDs;
in a so-called “closed” circuit, when the medical device has been reprocessed by an external reprocessing company at the request of the healthcare facility.
The decree defines the reprocessing process and provides for the implementation of a quality management system by the manufacturer or external reprocessing company.

A specific traceability obligation for used DMUUs to be reprocessed falls to:

healthcare facilities, until they are sent for reprocessing, with the assistance of the manufacturer or external reprocessing company;
the manufacturer or external reprocessing company, throughout their own supply chain, until they are placed on the market or returned to the healthcare facility.
Any serious incident involving DMUUs is notified to the French National Agency for the Safety of Medicines and Health Products by healthcare facilities and the manufacturer or external reprocessing company is informed.

Next Steps

Several calls for applications are expected, the terms and conditions of which will be set by order of the Minister of Health:
for the participation of healthcare facilities in the experiment;
for the participation of individuals or legal entities (i) who will fulfill the obligations incumbent on manufacturers, for open-circuit reprocessing; or (ii) as an external reprocessing company, for closed-loop reprocessing.
IGAS Report No. 2023-085R/IGEDD No. 015247-01 identified a single company, located in Germany, likely to reprocess UMDs within the next two years.

The report calls for an objective assessment of the ecological benefits of UMD reprocessing and for this lever to be put into perspective with other means of decarbonizing medical devices.

In accordance with Decree No. 2025-895,
a steering committee will meet at least three times a year to monitor and operationally implement the experiment;
an evaluation committee will prepare a report, based on which the Minister of Health will decide whether to generalize all or part of the experiment, extend it, or terminate it.