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.

Medical Remanufacturing

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.

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Our product catalogue

We offer a broad range of medical devices, including electrophysiology and surgical devices, and are always looking for new products to add to our portfolio.

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Our product range contains various devices for use in the EP lab, including electrophysiological catheters and cables, 3D mapping catheters as well as bundles containing 3D mapping catheters and matching reference electrodes.

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Our surgical portfolio includes remanufactured ultrasonic shears, ophthalmology devices, vascular coagulation catheters and flexible endoscopes.

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Safety is our top priority

Our 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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Clinical support from Vanguard

Our clinical support enables you to operate your EP Lab independently:

  • Our clinical support team has years of experience performing diagnostic catheter examinations and is happy to provide you with advice and assistance.
  • In addition to providing technical training for resident doctors and nursing staff, we can also support with 3D mapping procedures on site.
  • We provide device workshops tailored to your individual needs.