A Success Story: The UK Leads the Way
Stepping Hill Hospital, part of the Stockport NHS Foundation Trust, has demonstrated the effectiveness of remanufacturing through its Green Plan and the introduction of a single-use device remanufacturing program. In 2023/24 alone, the program saved over £40,000 and reduced CO₂ emissions by 209 kg—simply by reusing surgical instruments such as ultrasonic scalpels.
The benefits are clear: remanufactured medical devices are not only 30–50% more cost-effective, but they also reduce waste and reliance on vulnerable supply chains. This makes them a win-win solution for both hospitals and the environment.
France Takes a Step Forward
While many European countries have already adopted remanufacturing practices for medical devices, EU regulations permit this only if national laws explicitly allow it. This “opt-in” model, outlined in the Medical Device Regulation (MDR), also requires notification to the European Commission. These provisions make adoption challenging by creating additional regulatory barriers and offering no incentives. In some countries, healthcare and industry stakeholders must actively push for change to overcome linear, outdated regulations. France is one such case.
Despite being recognized as a leader in the circular economy, France has historically prohibited the remanufacturing of medical devices. However, a new pilot project could mark a turning point. The French government plans to conduct a two-year trial across four healthcare facilities to evaluate the safety, cost efficiency, and sustainability of remanufacturing single-use devices. The results could pave the way for legislative reform.
The Future of Remanufacturing in Europe
Alongside the UK and France’s pilot projects, remanufacturing single-use devices is already permitted in countries like Belgium, Croatia, Germany, Ireland, the Netherlands, Spain, Portugal, Sweden, and Israel. Globally, commercial and regulated remanufacturing is also practiced in the United States, Canada, Japan, Israel, and Australia.
Despite these successes, regulatory hurdles remain. The EU MDR’s “opt-in” model continues to hinder adoption across additional Member States. The Association of Medical Device Reprocessors (AMDR) is advocating for simplified regulations to improve access to remanufacturing across Europe.
With growing support from researchers, healthcare providers, and policymakers, remanufacturing single-use medical devices could soon become a cornerstone of sustainable healthcare systems—both in Europe and worldwide.
