EU Medical Device Regulation (MDR)

This course describes basic information concerning the European Medical Device Regulation and the CE marking of medical devices. Topics in this course include: History, Definitions, Approach, Quality System, and General Classifications and Rules. After completing this course, learners will be able to identify the basic components of the EU Medical Device Regulation (MDR).

After this course learners will be able to identify the basic components of the eu medical device regulation. recognize the definitions and classifications that describe the devices that fall under this regulation. identify other directives and regulations that might apply to medical devices sold in eu countries.