ABOUT MDR
EU Regulation 2017/745 on medical devices (MDR) entered into force at the end of May 2017 and applies from May 2021 after a transition period.
The new regulation replaced the Medical Devices Directive (MDD).
The purpose of the regulation is to significantly improve the quality, safety and reliability of medical devices and market surveillance mechanisms.
DESIGNATION
NEOEMKI LLC. is a notified body (NB1011) registered in the NANDO database for conformity assessment of medical devices according to the MDR.
The area of designation (MDR codes and certification routes) is included in the Notification details.
The designation is valid with the published and effective content in the NANDO database.
CERTIFICATION PROCESS (flow diagram and process description)
This flow diagram helps our Clients in review the certifcation process.
