In July, the Federal Council voted by majority to prohibit the use of reprocessed single-use medical devices if they are “CE-certified.” This means that the use of these products would be banned if it is proven that reprocessed products meet all essential safety and performance requirements set by the Medical Device Regulation for medical devices. The proposal originated from the Ministry of Labour, Health, and Social Affairs of North Rhine-Westphalia. However, it is based on incorrect assumptions and contradicts the recommendation of the Federal Ministry of Health (BR-Drs. 251/24). Below, we have provided a legal assessment of the situation.
Incorrect Premise 1: CE Reprocessing Is a Novelty
In a statement from the NRW Ministry of Health dated 18.07.2024, provided upon request, the following rationale for the proposal was given:
“The reprocessing of single-use products according to Article 17(2) of Regulation (EU) 2017/745 on medical devices (MDR) has, according to the majority opinion of the federal states, not been permitted in Germany until now.”
This perspective is inaccurate. CE reprocessing of single-use devices with certification from Notified Bodies in healthcare has been regulated for decades. The previous EU Directive 93/42/EEC, known as the Medical Device Directive (MDD) and superseded by the MDR in 2021, explicitly permitted it, commonly referred to as “remanufacturing as new.” Article 1(2)(f) of the MDD states:
“The obligations imposed on the manufacturer by this Directive shall also apply to any natural or legal person who assembles, packages, processes, refurbishes, and/or labels one or more pre-fabricated products and/or assigns them a specific purpose as a product with a view to their placement on the market in their own name.”
According to Article 1(2)(h) of Directive 93/42/EEC, the manufacturer obligations of the MDD also applied to “remanufacturing as new.”
Thus, the notion that remanufacturers placing products on the market are treated as manufacturers and equated with original manufacturers is not a recent development. Vanguard AG, for instance, received its first CE certifications from a Notified Body based in Germany in 2011 and has since introduced around 250,000 CE-reprocessed single-use devices to the German market.
Germany has already notified the European Commission of the permissibility of reprocessing single-use devices in accordance with Article 17(2) MDR as well as Article 17(3) and (4) MDR.
Incorrect Premise 2: CE Reprocessing Is Not Safe
The second incorrect assumption underlying the Health Committee’s recommendation in the Federal Council (BR-Drs. 251/1/24) is evident in the following statement:
“The provisions under Article 17(2) of Regulation (EU) 2017/745 (MDR), i.e., complete manufacturer obligations including full conformity assessment procedures, do not currently ensure that the original product for CE reprocessing (the used single-use product) has not been misused, mistreated, or used on critical patients. This can only be ensured through contracts within the framework of CS reprocessing.”
The claim that “this can only be ensured through contracts within the framework of CS reprocessing” is inaccurate. Contracts also specify how original products for CE reprocessing should be handled within healthcare facilities. These agreements form part of the conformity assessment process for CE reprocessing and are subject to review by a Notified Body. CE-certified reprocessed medical devices are demonstrably in compliance with all applicable essential safety and performance requirements of the MDR—standards that also apply to new products.
Issuing regulations based on factually incorrect assumptions should not occur in a constitutional state like Germany and should, rightly, prompt significant public concern. Consequently, an official statement from the Federal Ministry of Health, where the Federal Council’s decision now awaits action, is highly anticipated. Notably, the Ministry has already informed Handelsblatt of its intention to continue permitting CE reprocessing.
Our gratitude goes to Dr. Christian Jäkel, physician and specialist in medical law, and Dr. Hagen Thielecke, Head of Research and Development and Regulatory Affairs, for their contributions to this assessment with their legal and regulatory expertise.
