What Must Be Reported
The three MDR-reportable event types
Under 21 CFR Part 803, manufacturers must report events to FDA when they receive or become aware of information suggesting that a device may have:
1. Death
The device may have caused or contributed to death of a patient, user, or other person.
2. Serious Injury
The device may have caused or contributed to a serious injury — defined as an injury that:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to body structure
- Necessitates medical or surgical intervention to preclude permanent impairment or damage
- Requires in-patient hospitalisation
3. Malfunction
The device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
The US "malfunction" reporting requirement is broader than in many other jurisdictions — it applies even when no death or injury occurred, if recurrence of the malfunction could cause such outcomes.
Who must report
| Party | Reports deaths to | Reports serious injuries to | Reports malfunctions to |
|---|---|---|---|
| Manufacturer | FDA | FDA | FDA |
| Importer | FDA and Manufacturer | Manufacturer | Manufacturer |
| User facility | FDA and Manufacturer | Manufacturer | — (not required) |
What information triggers a report
A report is required when the manufacturer receives or otherwise becomes aware of information — including:
- Customer complaints
- Service records
- Scientific literature
- Information obtained during post-market surveillance
- Reports from employees