The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market
March 25, 2021 - CA USPanelcompliance
panelcompliance@gmail.com
Phone:8004479407
Overview: The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance. Also, learn how to plan an efficient transition.