Summation
- The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.
- This once again demonstrates that Neoss Group is at the forefront of their commitment to ensuring that their products adhere to the highest standards for the benefit of their customers and their patients.
- 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.
Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments. This certification adds to the previous MDR certification of Neoss’ Quality Management System and Class I Reusable instruments that was granted in 2022. This signifies that Neoss Group’s Quality Management System and its 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. 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.” Dr. Robert Gottlander, President and CEO of the Neoss Group.
This once again demonstrates that Neoss Group is at the forefront of their commitment to ensuring that their products adhere to the highest standards for the benefit of their customers and their patients. They are also one of the first 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. 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.” Mr. Fredrik Engman, CTO and co-founder of Neoss.”
The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making. The new MDR regulation creates a robust, transparent, and sustainable regulatory framework, improving clinical safety and creating fair market access for manufacturers and healthcare professionals. The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.
