Different Certification, Same Quality: AlCath Catheters Now Reprocessed as a Service

On 30 June 2025, the previous CE reprocessing and placing on the market was discontinued. Since July, these catheters have been reprocessed exclusively under contract reprocessing (CS), in accordance with Article 17(3) to (5) of Regulation (EU) 2017/745 (MDR).

The difference between CE and CS reprocessing is explained in more detail in this article. In short, the change means:

1. The medical devices undergo the same reprocessing procedure,including identification and labelling, cleaning and disinfection, sterilisation, and various tests and inspections, etc. The products from both reprocessing models are equally safe and functional, and equivalent in quality to OEM new devices.
2. Vanguard AG no longer purchases the AlCath catheters from hospitals to place them on the market as medical devices. Instead, the reprocessed device must be returned to the original healthcare institution that submitted it. As a result, healthcare institutions remain the legal owners of the catheters.

Of course, it remains possible to sell other medical devices to Vanguard AG. For any questions or individual enquiries, please contact our customer service team or your local field service representative

The term or trademark AlCath are trademarks of the original manufacturer BIOTRONIK SE & Co. KG (Woermannkehre 1, 12359 Berlin, Germany) or or an affiliated company.