Neoss Group, a leading innovator in dental implant solutions, proudly announced that it has received EU Medical Device Regulation (MDR) certification from its Notified Body, the BSI Group, Netherlands B.V., for its implants and abutments. This certification supplements Neoss’ previous MDR certification of its Quality Management System and Class I Reusable instruments, granted in 2022. It signifies that Neoss Group’s Quality Management System, implants, and abutments meet the requirements of the new MDR implemented by the European Union.
“MDR is one of the most thorough medical device regulations in the world,” said Dr. Robert Gottlander, president and CEO of the Neoss Group. “It ensures that medical devices meet the highest standards. The certification shows that we are in the forefront of implant solutions and that we provide best in class quality and care to our customers and their patients.”
This reaffirms Neoss Group’s commitment to ensuring its products adhere to the highest standards for the benefit of both its customers and their patients. They are also among the pioneering companies in the dental device field to achieve MDR certification for their products.
“The MDR certification gives Neoss the freedom to continue innovating intelligent solutions that benefit our customer and their patients,” said Mr. Fredrik Engman, CTO and co-founder of Neoss. “The MDR certification also shows that Neoss products are backed with clinical evidence of the highest standard and ensures that the products are continuously monitored in post-market studies.” ”
The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), aligning EU legislation with technical advances, changes in medical science, and progress in law-making. The new MDR regulation establishes a robust, transparent, and sustainable regulatory framework, enhancing clinical safety and providing fair market access for manufacturers and healthcare professionals. It includes crucial improvements such as establishing a comprehensive and accessible EU database on medical devices, incorporating a device traceability system based on unique device identification.
Neoss was founded with a vision to enhance dental implant treatments for both clinicians and patients. Leveraging extensive expertise in dental implant procedures, we are committed to developing user-friendly and cost-effective solutions that enhance the efficiency of dental professionals and improve patient outcomes. Our products and solutions are designed, researched, and developed in Gothenburg, Sweden – the birthplace of Osseointegration and the renowned pioneer, Professor Per-Ingvar Brånemark.
You can have confidence knowing that our offerings are supported by scientific research and long-term clinical results, providing you and your patients with peace of mind. To find out more, visit https://neoss.com.