X-Guide Receives EU MDR Certification

X-Guide Receives EU MDR Certification

X-Guide® Is The First Dental Surgical Navigation System To Receive EU MDR Certification

Overview

X-Nav Technologies, LLC announced that the X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR.

About EUMDR

• The EU MDR is one of the most rigorous medical device regulations in the world today, intended to ensure a higher standard of safety and quality in the development and manufacturing of medical devices distributed in the European market.
• The regulation requires a thorough audit of a company's Technical Documentation, Clinical Evidence, and Quality Management System. 
• The completion of this process certifies that the X-Guide System delivers the claimed clinical