Victory for Science and Sustainability: Bundesrat Overturns Ban on Reprocessed Medical Devices

We are relieved and pleased by this groundbreaking decision. It confirms that evidence-based arguments and proven safety standards will continue to set the benchmark for medical innovation,” says Ulrike Marczak, CEO of Vanguard AG. “This ensures the continuation of an environmentally friendly, economically viable, and absolutely safe practice for patients, which has been well established in Germany for over a decade.”

Strengthening Sustainability and Economic Efficiency

With this decision, medical remanufacturing is reaffirmed as a proven and safe solution for reducing emissions and waste in the healthcare sector. CE reprocessing enables significant resource savings each year while providing financial relief for hospitals and reducing dependence on global supply chains.

According to a study by the Fraunhofer Institute, a reprocessed cardiac catheter, for example, generates up to 50% fewer CO₂ emissions compared to a newly manufactured one. Thus, the Bundesrat’s decision not only enhances cost efficiency but also contributes to the healthcare sector’s climate goals.

A Signal for Innovation and Competitiveness

This decision also strengthens the credibility of European CE certification processes. Regulations will continue to follow the scientifically grounded requirements of the EU Medical Device Regulation (MDR), which ensures uniform safety and quality standards for all CE-certified medical devices – whether newly manufactured or remanufactured.

“With this decision, Germany remains an innovation hub for sustainable medical technology,” says Ulrike Marczak. “Our expertise in circular economy solutions remains intact – to the benefit of the environment, hospitals, and patients alike.”