CeraRoot is pleased to announce the receipt of the EU Medical Device Regulation (MDR) Quality Management System certification by its Notified Body, the BSI Group, the Netherlands B.V. (NB 2797). This means that CeraRoot’s Quality Management System, and the corresponding ceramic dental implants, meet the requirements of the new MDR implemented by the European Union.
CeraRoot is the first CERAMIC DENTAL IMPLANT company to achieve MDR certification.
Receiving the MDR certificate is an important milestone for CeraRoot and it demonstrates that our products are manufactured according to the highest quality and safety standards.
The new European Union Medical Device Regulation (EU) 2017/745 was due to become fully active on May 26, 2021. It replaces the older Directive 93/42/EEC on medical devices.
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