1. Malfunction MDR Reporting Requirements
Any event which reasonably suggests that a device has or may have caused or contributed to death or serious injury is a reportable event. For manufacturers and importers, an added requirement of reporting includes a malfunction that if it recurred would be likely to cause or contribute to a death or serious injury.
2. From Information to Report Generation
Be clear on what types of information "reasonably suggests" something is a reportable event. Professional opinions and observations, along with scientific or medical facts, all meet the definition of "reasonably suggests".
3. Filing FDA 3500A
The user facility must file form FDA 3500A for death or serious injury within 10 working days. For death, the report must be filed to both the FDA and the manufacturer, for serious injury, to the manufacturer and only to the FDA if the manufacturer is unknown. An annual report must also be filed to the FDA using form FDA 3419 on January 1.
4. MDR Reportable Event
Even if user error is the reason why a device caused or contributed to a death or serious injury, MDR still must be filed.
5. Recall Letter
When a correction or removal is initiated, a written report must be submitted within 10 working days by the recalling firm.
6. Device User Facility
Physician's offices, school nurse offices and employer nurses/health offices are not considered device user facilities.
Routine servicing, stock recoveries, market withdrawals and actions to improve quality or performance but which do not reduce a risk or remedy a violation are exempt from reporting.
8. Process Flow
Meeting deadlines, including all required information and communication, and having the correct processes and procedures in place are all crucial.