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:
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.
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.
Medical remanufacturing contributes to the creation of a circular economy within the medical device industry. The impact on climate change is substantially reduced and the planet’s resources conserved, while costs for medical facilities are substantially reduced, all without compromising on safety or performance.
Learn moreWe offer a broad range of medical devices, including electrophysiology and surgical devices, and are always looking for new products to add to our portfolio.
Learn moreOur remanufactured medical devices are restored to “as new” functional and safety standards with matching warranty. They are used for the same indications as specified by the original manufacturer. We assume matching product liability.
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