Auxein Becomes Asia’s First To Achieve EU-MDR Certification For Trauma Orthopaedic Solutions

Auxein, a global innovator in orthopaedic and arthroscopy solutions, has achieved the prestigious European Union Medical Device Regulation (EU-MDR) certification for its Trauma Plating, Screws, and Nailing Systems, including the Tibia Plate and Screw and Femoral Nailing System. 

In a press statement on Saturday, the company stated that this milestone made Auxein the first orthopaedic implant manufacturing organisation in Asia to secure EU-MDR certification for these solutions.

The certification, issued by DNV Norway, further strengthens Auxein’s position as a leader in the global medical device market. It ensures the company’s products meet the highest safety, performance, and regulatory compliance standards required for distribution across Europe.

Auxein’s  R&D and manufacturing facilities are recognised for adhering to rigorous standards in medical device production. In addition to the EU-MDR certification, the company holds multiple global certifications, including the Medical Device Single Audit Program (MDSAP), EN ISO 13485, and USFDA 510(k). 

Achieving EU-MDR certification represents a significant step toward ensuring that Auxein’s orthopaedic implants, including joint arthroplasties, trauma devices, and fixation systems, comply with stringent European safety and performance standards. This compliance enhances product traceability, clinical evaluation, and patient safety, reinforcing Auxein's role in the European medical device market.

Gaurav Luthra, Vice President of Global Manufacturing and Regulatory Head at Auxein, commented on this achievement, saying, “Securing EU-MDR certification is a testament to our relentless dedication to providing the safest, most innovative orthopaedic solutions. This accomplishment, along with our extensive global certifications, positions us to drive advancements in healthcare on a global scale.”