2-day In-person Seminar (October 7-8, 2015)

Medical Device Reporting (MDR)

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report significant medical device adverse events to the Food and Drug Administration (FDA). FDA uses this information to identify and respond to problems associated with medical devices.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA.  Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up and the work shop will review examples of MDR’s in various phases for review and group discussion.

The workshop will place emphasis on the following: (1) event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or (2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: (i) May have caused or contributed to a death or serious injury, or (ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective for user facilities and device manufacturers.

This hands-on interactive workshop is designed to cover the entire MDR process from end-to-end. Examples of MDR’s and recent FDA enforcement actions specifically related to failure to submit MDR’s per FDA reporting timelines, failure to follow MDR procedures and other issues will be addressed and discussed with the audience.

Through examples, participants will review MDR’s, MDR SOPs and the various forms and reports associated with the MDR process as well as FDA inspectional objectives during inspections

Some MDR training highlights...

  • Understand the History of MDR Regulation and the Process
  • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
  • Who can submit Voluntary Reports to the FDA?
  • How does the FDA Use Medical Device Reports?
  • What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
  • What form should I use to submit reports of individual adverse events and where do I obtain these forms?
  • How will I know if I require more information about my medical device report?
  • Reporting device-related deaths and serious injuries and when these are not treated as a product complaint
  • Understand the manufacturer's reporting requirements and expectations
  • Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
  • Learn what constitutes a MDR and how to facilitate this for compliance success
  • Develop, maintain, and implement written MDR procedures and achieve compliance
  • Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary
  • Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to FDA through the MedWatch program

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For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: info@fdamap.com