Managing Your Medical Device Reporting (MDR) Program for Compliance Success

Overview: 

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

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. The statutory authority for the MDR regulation is section 519(a) of the FFD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990. 

Areas Covered in the Session:

  • 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

Who Will Benefit: This webinar will provide valuable assistance and guidance to all medical device companies and user facilities that are required to manage or comply with the provisions of the 21 CFR 803 MDR program. The employees who will benefit include:

  • All levels of Management for all departments and those who desire a better understanding or a “refresh” overview
  • QA/QC
  • Regulatory Affairs and Compliance
  • Engineering/Technical Services/Operations
  • Consultants
Speaker Profile

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407 
support@compliance4all.com