CE remanufacturing: remanufacturing with manufacturer responsibility
In CE remanufacturing, the medical device originally labelled as single-use becomes the property of Vanguard and is subsequently restored through a validated remanufacturing process. In accordance with Article 17(2) of the Medical Device Regulation (MDR), Vanguard assumes all manufacturer obligations as the remanufacturer.
The foundation of CE remanufacturing is a quality management system certified in accordance with EN ISO 13485, ensuring safe processes, traceability and structured process control.
In addition, the technical documentation includes all safety- and performance-related information required by the MDR and demonstrates compliance with all general safety and performance requirements. It also serves as the central basis for risk management, validation data and the required post-market obligations.
This ensures that the remanufacturing product can be used reliably in clinical practice.
CS remanufacturing: remanufacturing as a service
In CS remanufacturing, the medical device remains the property of the hospital and is remanufactured by Vanguard as a service. Formally, the remanufacturer is liable only for its own process within this framework. Vanguard, however, goes beyond this and assumes all manufacturer obligations, including product liability.
The basis of CS remanufacturing is the binding Common Specifications (CS), laid down in EU Implementing Regulation (EU) 2020/1207 and MDR 2017/745, and supplemented at national level by the MPDG, MPBetreibV and the KRINKO–BfArM recommendation.
In Germany, this form of remanufacturing is permitted provided that the CS and the KRINKO recommendations (issued by the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute) are complied with.
The CS define clear technical and organisational requirements for remanufacturing, including validated procedures covering cleaning and disinfection, functional testing, sterilisation and release. A quality management system in accordance with EN ISO 13485 is also mandatory.
As there is currently no designated notified body for the CS, this remanufacturing model is presently carried out under regulatory tolerance by the authorities.
CS remanufacturing therefore represents a clearly regulated procedure that enables legally secure and quality-oriented remanufacturing on behalf of the hospital.
Regardless of the chosen remanufacturing model, the remanufacturing of medical devices originally labelled as single-use products is subject to clear notification and reporting obligations. Notification requirements ensure that remanufacturing activities are made transparent in advance. Reporting obligations apply if relevant incidents or reportable changes occur during ongoing operations. This ensures traceability and regulatory assurance of remanufacturing activities.
KRINKO: hygiene standards as a foundation
KRINKO refers to the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI). Together with the Federal Institute for Drugs and Medical Devices (BfArM), it has published the KRINKO–BfArM recommendation “Requirements for hygiene in the remanufacturing of medical devices”.
This recommendation forms the basis for safe, traceable and standardised remanufacturing of reusable medical devices and is regarded as the recognised state of the art in science and technology. Under Section 8 of the Medical Devices Operator Ordinance (MPBetreibV), its implementation is mandatory in Germany.
The KRINKO–BfArM recommendation describes in detail how safe and hygienic remanufacturing must be carried out. This includes not only the validation of procedures, but also the continuous verification of their effectiveness. Medical devices must be classified according to their risk, while cleaning and disinfection should be carried out mechanically wherever possible. At the same time, the recommendation emphasises the importance of qualified personnel who receive regular training and are responsible for the professional release of remanufactured devices. Comprehensive documentation and clearly defined organisational structures, in conjunction with an effective quality and risk management system, provide the necessary foundation.
Overall, the KRINKO–BfArM recommendation establishes a binding framework that prevents recontamination and reliably ensures quality and patient safety.
Different requirements – one quality benchmark
Although the products remanufactured by Vanguard AG differ in their certification and are subject to different regulatory requirements, they all undergo the same validated remanufacturing process and meet the same high standards of safety, functionality and quality as OEM new products.
By combining KRINKO, CE and CS, Vanguard brings together a system that links safety, quality and sustainability – contributing to greater resource efficiency in healthcare.
Information and advice on medical remanufacturing
This topic is complex and often raises questions in practice. Further information, practical application examples and clarification of topics points are available at any time through dedicated points of contact.
