Single-use devices remanufactured by Vanguard
We give new life to single-use medical devices without compromising on safety or performance. The EU regulatory framework allows two types of medical remanufacturing:
Medical remanufacturing with CE certification
The legal basis is provided in Article 17 (2) of the MDR requiring a medical remanufacturer to assume obligations of a manufacturer set out in the MDR.
Medical remanufacturing with CS certification
The legal basis is provided by Article 17 (3) and (4) of the MDR, as well as the Common Specifications issued by the EU Comission. These require a medical remanufacturer to assume the core obligations of a manufacturer as defined by the Common Specification and National Law.
Vanguard has established equivalent remanufacturing processes for both types of medical remanufacturing. The difference between the two lies in the approval and certification procedure.