This means that the pilot project for the regulated remanufacturing of selected single-use medical devices can now move into practical implementation. Ten public and private healthcare institutions, comprising a total of 15 electrophysiology (EP) hospitals, have been approved to participate. The aim of the pilot phase is to evaluate the technical feasibility of the regulated remanufacturing of specific single-use medical devices in everyday clinical practice and to assess whether the model can be permanently established and expanded in the future. The pilot project will run until 1 September 2028 and will be overseen by a steering committee and an evaluation committee under the supervision of the French Directorate General for Health.
Clear Requirements for Implementation
The newly published requirements provide greater clarity on how the pilot project is to be implemented in everyday clinical practice. They regulate, among other things, the collaboration between the participating healthcare institutions and Vanguard as the only qualified external remanufacturing company, the contractual framework, and patient information.
For the practical implementation, Vanguard can already build on existing experience in France: Vanguard is already working with around half of the participating EP hospitals to collect used medical devices. The next step is to integrate additional hospitals into the process, conclude the contractual arrangements for the use of remanufactured medical devices, and prepare the procedures so that the first sales and clinical use in patients can begin from September 2026.
Importance for Electrophysiology
The pilot project is of particular relevance to electrophysiology. This field makes extensive use of complex single-use medical devices, where circular economy models can make an important contribution to resource conservation, waste reduction, and security of supply.
Medical Remanufacturing provides the opportunity to make suitable products available for reuse through a regulated and quality-assured process. France is now assessing in practice how this form of remanufacturing can be integrated into existing clinical workflows and what environmental, organisational, and economic effects are associated with it.
An Important Step for Medical Remanufacturing in Europe
For Vanguard, the launch of the pilot project is an important signal, both for France and for the overall development of Medical Remanufacturing in Europe. What has already been possible and established in practice for many years in ten Western European countries is now gaining further momentum through the French pilot project.
The French pilot project also demonstrates the importance of a harmonised European framework. The pilot phase considers both CE remanufacturing and remanufacturing in accordance with the Common Specifications, highlighting the potential that regulated remanufacturing offers for Europe. Where the relevant requirements are met, processes are implemented under quality assurance, and products are released in a fully traceable manner, Medical Remanufacturing should in future be easier and more reliable to implement across Europe. The further development of the EU Medical Device Regulation offers an important opportunity to achieve this.
Last year, we reported on the legal framework of the French pilot project. With the current decree, the project is now moving to the next stage: practical implementation. More about the legal framework of the French pilot phase in our first article.
The official publication of the French requirements is available on Légifrance.
