frequently asked questions
Explore our FAQs about device remanufacturing, certification, and compliance.
FAQs
Who is Vanguard?
Vanguard AG is a European specialist in the medical remanufacturing of selected single-use medical devices with over 1,500 customers. The company remanufactures devices under strict regulatory, quality and safety requirements.
What is medical remanufacturing?
Medical remanufacturing, also referred to as reprocessing in some regulatory contexts, is a controlled process applied to selected single-use medical devices to enable their safe reuse. Depending on the product, this may include validated cleaning, disinfection, sterilisation and functional testing, as well as restoring and verifying technical and functional safety. In the EU, remanufacturing of single-use devices is regulated under the Medical Device Regulation (EU) 2017/745 and applicable national rules.
Where does the remanufacturing take place?
The remanufacturing process takes place at Vanguard’s three certified facilities located in Germany.
Can we visit the facilities?
Yes. Facility visits can be arranged on request, subject to availability and applicable access, confidentiality and hygiene requirements.
Is the remanufacturing of single-use devices permitted in Ireland?
Yes, under defined regulatory conditions. Ireland permits the remanufacturing of single-use devices within the framework of the EU Medical Device Regulation and national implementing rules. Reprocessors must comply with the applicable MDR requirements, including conformity assessment, CE marking, traceability and labelling. In this model, the reprocessor assumes the relevant manufacturer obligations and liability for the remanufactured device placed on the market.
https://www.irishstatutebook.ie/eli/2021/si/261/made/en/print
What type of devices can Vanguard remanufacture?
(J&J Carto 3, Boston Scientific, Bard, Medtronic)
The current CE portfolio listing is attached (EP & surgical): https://www.vanguard.de/en/devices/catalogue/
Vanguard remanufactures selected CE-marked medical devices, with a strong focus on electrophysiology and additional selected surgical applications. The exact portfolio depends on the current CE-marked product scope and may change over time. A current portfolio overview can be provided on request.
Can Vanguard remanufacture devices that are not currently part of its CE-marked portfolio?
Potentially, but only after a full assessment and validation process. New products must meet strict technical, regulatory and quality requirements before they can be included in the CE-marked portfolio. This process can be extensive and may take a considerable amount of time. Vanguard has a current CE pipeline of cardiac and surgical devices.
How many times can each device be remanufactured?
The maximum number of remanufacturing cycles is product-specific. Depending on the device type, material properties, technical requirements and the validated process covered by the relevant conformity assessment and certification by the Notified Body, this may range from one to four cycles. Devices are only released when they meet all defined quality, safety and performance requirements.
How do Vanguard keep track of this?
Each product is laser-marked through the cycle with an individual Serial number per product called UDI PI.
Can remanufactured devices be placed back on the market, and who takes responsibility?ck into the market? Who takes responsibility?
Yes, provided they meet the applicable regulatory requirements. Remanufactured devices placed on the EU market carry the required CE marking. Vanguard assumes the relevant manufacturer responsibilities for the remanufactured device, including quality assurance, traceability and regulatory compliance. Vanguard’s products are identified through UDI-compliant coding.
What sustainability benefits can remanufactured devices offer?
Medical remanufacturing can reduce environmental impact by extending the useful life of selected medical devices and reducing the need for new production. A Fraunhofer UMSICHT study on electrophysiology catheters found that medical remanufacturing reduced the carbon footprint by more than 50% and resource consumption by more than 28% compared with manufacturing a new catheter. Results may vary by product category and process.
See also the following recent study and report from the UK:
Are remanufactured devices available through HSE procurement routes?
Yes. Selected CE-marked Vanguard devices are qualified under DPS 202164:1 – DPS Qualification for Electrosurgery Equipment and Neurology Products. Availability may depend on the current portfolio, product category and applicable procurement route. Please contact us for the latest information on availability, applicable frameworks and ordering options.
What other countries doe remanufacture/ reprocess SUDs
Rules differ by country. In the EU, the reprocessing of single-use devices is only permitted where national law allows it and the requirements of the MDR and national legislation are met. Several European countries permit reprocessing under defined conditions, including for example Germany, Spain, Belgium, the Netherlands, Denmark, Portugal; Sweden, Iceland, Croatia and Slovenia. Other countries restrict or prohibit it, and national rules may change over time. Outside the EU, reprocessing or remanufacturing is also established in markets such as the United States, Canada, Japan and Australia, although regulatory frameworks differ from the EU system. The European Commission provides an overview of national rules.
Is anyone doing this in Ireland?
Yes, there are examples of Irish healthcare institutions engaging with remanufacturing and reprocessing initiatives. For example, Cork University Maternity Hospital and Cork University Hospital were recently awarded an HSE Sustainability Award for this initiative. Specific implementation depends on the healthcare institution, product scope and applicable regulatory and procurement requirements.
https://zehnacker.ie/cork-university-maternity-hospital-wins-hse-climate-sustainability-award/
Do Original Equipment Manufacturers (OEMs) typically support remanufacturing of their devices by 3rd parties such as Vanguard?
Original equipment manufacturers do not typically actively support third-party remanufacturing of their single-use devices. In some markets, there have also been disputes around the use of remanufactured devices in hospitals, including legal proceedings concerning competition, access and market practices. Recent U.S. rulings have addressed related questions around competition, market access and the use of remanufactured medical devices.
