08.03.2024 / company news

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Bonebridge Receives EU MDR Certification

Zug, Switzerland, 08 March 2024 – Bonebridge is proud to announce that it has received the European Medical Device Regulation (MDR) certification. Accordingly, all Bonebridge products are now fully approved in all countries of the European Union and Switzerland.

Receiving the EU MDR 2017/745 certificate means that Bonebridge products meet the new European regulatory standards regarding the development, manufacturing, and distribution of medical devices. It further strengthens the company’s reputation as a respected and trusted partner in orthopaedic trauma and also marks an important milestone in Bonebridge’s achievements to date.

“This is a transformative moment in Bonebridge’s young history,“ CEO Christof Gerber comments. “We launched our first smart orthopaedic trauma implant – the SALGINA Distal Radius Plate – in 2019, and we have come a long way since these beginnings. As our product portfolio has continued to grow and we have branched out into markets in the United States, Australia and New Zealand, we remain committed to ‘reducing complexity’ in fracture care and to maintaining the highest standards in patient safety. The successful attainment of the MDR certification is the result of a collective team effort, and I would like to thank everyone involved for their dedication and hard work – most notably our Head of QM&RA Michelle Gumpelmayer and her team, as well as our colleagues in Clinical Affairs and R&D.”

With the MDR certification, Bonebridge has paved the way for current and future product developments and is looking forward to further strengthening and expanding its portfolio for customers in Switzerland and abroad.

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