MDR Regulation 1: Overview and General Provisions

FDA Investigators, compliance officers, medical device manufacturers, user facilities, and importers need to be aware of the Medical Device Reporting (MDR) regulation and its provisions. This course describes the key characteristics of the MDR regulation and its preamble as well as the key terms used in the MDR regulation. Topics in this course include: Origin, Device and Modernization Amendments, Characteristics, , and Application. After completing this course, learners will be able to identify the key characteristics of the MDR regulation and its preamble as well as the key terms used in the MDR regulation. Also, you will be able recognize to whom the MDR regulation applies and who is exempt from the regulation.

After this course learners will be able to identify the key characteristics of the mdr regulation and its preamble as well as the key terms used in the mdr regulation. recognize to whom the mdr regulation applies and who is exempt from the regulation.