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Since the mid 1980s, the FDA has expressed concerns about their need to be informed of adverse events that may have been caused by or contributed to legally marketed medical devices.  As such, they promulgated the Medical Device Reporting regulation, 21 CFR 803, in 1984. The regulation requires reporting, within designated time periods, any death or serious injuries that may have been attributed to the devices, as well as any malfunctions of the device that could result in a death or serious injury. Failure to comply with the regulation results in the marketed device being misbranded.  So – are Medical Device Reporting regulations merely an additional bureaucratic regulation or do they add value and benefit to the manufacturer?

Why Should You Attend:

Getting feedback on your products, both good and bad, is beneficial and can be an excellent learning experience.  However, hearing issues and concerns about your marketed medical devices and not doing anything about it can result in dire consequences for both patients and the manufacturer.  Failure to comply with healthcare regulatory compliance for customer complaints in itself can result in the FDA considering your products to be adulterated and/or misbranded; failure to follow processes that meet the FDA’s expectations can result in civil and criminal penalties, including fines and imprisonment!

This webinar will provide attendees with tools and techniques to help ensure that regulatory requirements for assessing complaints to determine if they constitute a reportable adverse event (MDR) and the processes that must be followed to report those incidents on a timely basis.  Voluntary compliance is not an option and complete understanding of the Agency’s requirements and expectations is of utmost importance to minimize potential future mandatory decrees to compel an organization to “do the right thing” and take appropriate actions to protect its customers and patients.

Areas Covered in the Session:

This session will discuss:

  • Medical Device Reporting History, Overview, and Basics
  • Consequences for Non-Reporting and Over-Reporting
  • Definitions:  Serious Injury, Death, Malfunction, User Error, Reportable Event
  • When do malfunctions need to be reported?
  • The eMDR System
  • MDR for Manufacturers and Importers
  • MDR for User Facilities
  • The MAUDE Database

Learning Objectives:

This webinar will assist the participant in:

  • Understanding the regulatory requirements for reporting medical device adverse events to the FDA
  • Obtaining clarity on constitutes a reportable adverse event (MDR)
  • Knowing what the potential penalties for not properly reporting MDRs

Who Will Benefit:

  • Quality and Regulatory Managers
  • Quality and Regulatory Specialists
  • Complaint/MDR Coordinators
  • CAPA Coordinators
  • Medical Device Importers
  • Hospitals and Long Term Care Facilities
  • Pharmacies



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