" The EU MDR is the European Union Medical Device Regulation 2017/745 that were released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR regulations is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
This regulatory framework is intended to better identify medical devices, as well as standardizing data and technological advances through an EU database (Eudamed). The regulation EU MDR is intended to be a regulatory framework for medical devices that can sustainably ensure health & safety while still encouraging innovation."
Recently Launca Medical has udpated CE certification under new MDR regulation.
So far, Lauca Medical has completed the following certificates (not limited to) for Launca intraoral scanner DL-206 & DL-206P,
ISO13485, USFDA, China NMPA
Launca Medical is always making continuous efforts to provide better services and equipment for clinics around the world.