MDR Regulation 2: Device User Facility, Importer, and Manufacturer Reporting Requirements

Medical device manufacturers, user facilities, and importers need to identify and monitor significant adverse events involving medical devices. This course describes important terms crucial to understanding the Medical Device Reporting (MDR) regulation and its requirements as they relate to user facilities, importers, and manufacturers. Topics in this course include: User Facilities, Importers, Manufacturers, and Event Files. After completing this course, learners will be able to identify the requirements for electronic MDR submission, MDR procedures, and event files.

After this course learners will be able to recognize important terms crucial to the device user facility requirements of the mdr regulation. identify the mdr requirements as they relate to user facilities, importers, and manufacturers. identify the requirements for mdr procedures and event files.