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Neoss receives MDR certification for complete product portfolio

The dental implant company Neoss has recently achieved EU Medical Device Regulation certification for its NeoGen PTFE non-resorbable membranes, marking the completion of this regulatory compliance across its entire range of products and solutions. (Image: stoatphoto/Shutterstock)

Tue. 14 January 2025

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HARROGATE, England: Neoss Group has recently announced that it has obtained certification under Regulation (EU) 2017/745 (Medical Device Regulation—MDR) from its notified body, BSI Group Netherlands, for its NeoGen PTFE non-resorbable membranes. This certification completes the MDR certification for all Neoss products and solutions and adds to previous certifications of Neoss’s quality management system, implants, abutments and instruments. This means that Neoss Group’s quality management system and all its products and solutions comply with the requirements of the EU MDR legislation.

“We are pleased that Neoss has successfully navigated and achieved MDR certification with BSI for the full range of non-resorbable dental membranes. The review and certification processes are robust and require a high level of collaboration with manufacturers to ensure compliance with the new regulation. Our technical team at BSI has significant expertise in dental products,” stated Dr Chris Wylie, global head of orthopaedic and dental at BSI. “The completion of all initial certifications with Neoss reflects our progress in transitioning to MDR and supports the shared goal of continued patient access to safe and effective products under the new EU regulations,” he added.

“The NeoGen PTFE membrane, developed by Neoss, is an important product for both patients and clinicians. With proven effectiveness for guided bone regeneration, the membrane enables restored chewing function, speech and aesthetics for implant patients. MDR certification demonstrates that the NeoGen membrane is supported by rigorous testing, clinical evidence and ongoing studies, ensuring patients receive the best possible care and that dental professionals can rely on these products. This regulatory milestone once again shows that Neoss Group is at the forefront and that our products and solutions meet the highest standards of quality and safety, all for the benefit of our customers and their patients,” commented Fredrik Engman, chief technology officer and co-founder of Neoss. Engman developed the NeoGen PTFE membrane.

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