Is the Bundesrat banning CE reprocessing after over 10 Years in Germany?
Is the Bundesrat Voting Against the Credibility of CE Certification?
On Friday, July 5, 2024, an important vote is scheduled in the Bundesrat: it concerns a revision of the Medical Device Operator Ordinance, which could potentially include a ban on CE-certified products. These products have been approved in Germany for over 10 years and are an essential contribution to the circular economy in the healthcare sector. So why should they be banned?
The Importance of CE-Certified Products
For over a decade, and with over 250,000 products placed on the market, CE-certified single-use medical products that have been remanufactured have been a fixture in the German healthcare system. This practice is not only safe but also environmentally friendly and economically sensible. It helps reduce emissions and waste, lower costs in hospitals, and make supply chains less dependent on global factors. Despite these advantages, committees are now recommending that the Bundesrat ban these products – and without a solid evidence base.
Why should a CE-certified remanufactured product be considered inferior to a CE-certified new product? Such a distinction would undermine the entire approval process for medical devices.
Fact or Fiction: The Legal Basis
The Health Committee claims in its recommendation (printed matter 251/1/24) in point ten that the Federal Ministry of Health’s draft would, for the first time, generally declare “CE reprocessing” permissible in Germany and allow the use of reprocessed single-use products. However, this claim is false. Under the previous Directive 93/42/EEC on medical devices (MDD), CE reprocessing was already permissible in Germany and has proven to be a safe practice. For over 10 years and with approximately 250,000 products placed on the market, there is no evidence that reprocessed CE-certified products pose a higher risk to patients than new products.
Additionally, Germany has already notified the European Commission of the permissibility of reprocessing single-use products in accordance with Article 17(2) MDR and Articles 17(3) and (4) MDR: European Commission Notification.
The International Perspective: Why is the Global Practice of Remanufacturing Not Considered?
Why do committee members not also look at the global market for remanufacturing and include it in their risk assessment? Remanufacturing has been internationally established for decades, thanks in part to the AMDR, founded in 1999, whose only European member is Vanguard AG.
The Consequences of a Ban
A ban on the proven practice of CE remanufacturing would not only undermine the credibility of EU-wide conformity standards but also weaken Germany as an economic and technological leader. It would also be a setback for climate protection and cost-effective management in hospitals.
Conclusion
The upcoming vote in the Bundesrat could have far-reaching impacts on the German healthcare system. It is imperative that the decision supports a sustainable and economically sensible approach to healthcare. Banning CE remanufacturing would be a step backward for safety, environmental responsibility, and cost efficiency. The Bundesrat must recognize the value and credibility of CE-certified remanufactured products and vote to maintain their use in the healthcare sector.
