CE reprocessing of single-use devices means that Vanguard assumes full responsibility as a medical device manufacturer under the MDR. This includes technical documentation, clinical evaluation, post-market surveillance and vigilance.
The certification process was successfully completed within a few months. This was made possible through comprehensive preparation of the technical documentation and close coordination with the TÜV NORD CERT team.
The certificate was formally handed over by Nina Marx, Business Development Manager – Medical Devices, and Dr. Alain Steinmann, Head of Expert Team Biocompatibility – Clinics – Reprocessing of Medical Devices at TÜV NORD CERT, to Ulrike Marczak, Chief Executive Officer of Vanguard AG, and Dr. Hagen Thielecke, Director R&D / Regulatory Affairs Products.
“The MDR places the highest requirements on manufacturers of medical devices. Successfully obtaining MDR certification within this demanding regulatory environment confirms the quality of our processes and our consistent commitment to safety and compliance,” explains Dr Hagen Thielecke, Director R&D / Regulatory Affairs at Vanguard AG. “For us, this is not merely a formal milestone, but a clear commitment to responsible reprocessing at the highest regulatory level.”
For more than 25 years, Vanguard has stood for quality-assured reprocessing of medical devices and supports healthcare institutions in conserving resources and operating in an economically sustainable manner. The MDR certification reinforces this commitment and provides additional assurance for partners and customers.
