The MDR Network Group was started in May 1996. The goals of the group are to:
- Understand the FDA MDR reporting requirements (21 CFR 803);
- Share best practices of implementing the MDR regulations;
- Obtain a perspective of adverse event and product problem reporting from the user facility perspective;
- Understand the international reporting requirements for medical device adverse events;
- Understand common pitfalls and mistakes made by manufacturers; and
- 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.