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MDR Network Group

The MDR Network Group was started in May 1996. The goals of the group are to:

  1. Understand the FDA MDR reporting requirements (21 CFR 803)
  2. Share best practices of implementing the MDR regulations
  3. Obtain a perspective of adverse event and product problem reporting from the user facility perspective
  4. Understand the international reporting requirements for medical device adverse events
  5. Understand common pitfalls and mistakes made by manufacturers
  6. Network with other professionals who work specifically in the complaint, MDR, and international reporting areas

The MDR Network Group has also worked with the FDA to establish a two-way communication on MDR issues. The MDR Network Group received the Vice-Presidential Hammer Award from Al Gore in May 1999 for their partnership with the FDA towards reaching their common goal of patient safety.

Please check the OCRA Events Calendar for the next MDR Network Group meeting. If you would like to suggest a new topic, or would like to speak to the group on a particular subject, please contact Chris Posin at This email address is being protected from spambots. You need JavaScript enabled to view it..