Neoss Group proudly announces that we have obtained EU Medical Device Regulation (MDR) certification from our notified body, BSI Group Netherlands BV, for NeoGen PTFE non-resorbable membranes.
This certification completes the MDR certification for all Neoss products and solutions and adds to previous certifications of Neoss’ 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. 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,” stated Dr. Chris Wylie, global head – orthopaedic & dental, BSI.
“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,” said Fredrik Engman, CTO, co-founder of Neoss, and inventor of the NeoGen PTFE membrane.
About Neoss
Neoss offers intelligent products that are intuitively simple to use. Our products allow dental professionals to provide reliable and cost-effective treatments to their patients with excellent long-term results. Leading the market with ingenuity and integrity, we strive to set new standards. In developing smart treatment solutions and working closely with each practice, Neoss makes the complex less complicated. We call that Intelligent Simplicity. Headquartered in Harrogate, UK, with research and development based in Gothenburg, Sweden, the company has established a global footprint with a long-standing presence in key markets. To find out more, visit https://www.neoss.com.
