MDR Regulation 3: Requirements for Individual Adverse Event Reports

FDA investigators, compliance officers, medical device manufacturers, user facilities and importers need to know how to document and submit adverse event reports in a timely fashion. This course identifies the proper forms and timelines for reporting adverse events. Topics in this course include: Reporting, MEDWATCH, Deadlines, Codes, and Exceptions. After completing this course, learners will be able to recognize the proper forms and timeframes necessary for adverse event reporting and identify when it is not necessary to file a report.

After this course learners will be able to identify how user facilities, importers, and manufacturers report adverse events. recognize the proper forms to use to report adverse events, as well as the timeframes for reporting. identify when it is not necessary to report an event.