Medical Device Reporting (MDR)

What must a manufacturer report under Part 803?

Under 21 CFR Part 803, a manufacturer must report when it becomes aware of information reasonably suggesting that its device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction recurred. For a 30-day report, the manufacturer is considered aware when any employee becomes aware of information that reasonably suggests a reportable event, making complaint-intake escalation an important control.

What are the reporting deadlines?

Manufacturers file within 30 calendar days of becoming aware of a reportable event, and within 5 work days when the FDA requests 5-day reporting or when a reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to public health. Importers and user facilities have different reporting duties and recipients. Manufacturer reports are submitted electronically on Form 3500A or its electronic equivalent and generally appear in the MAUDE database.

How does MDR interact with recalls and corrections?

The same facts may trigger separate analyses under Part 803, the correction-and-removal reporting rule in 21 CFR Part 806 and the recall framework. They are not automatically coextensive: Part 803 asks whether an event is reportable, while Part 806 asks whether an initiated correction or removal meets its reporting criteria. A company should coordinate the timelines, health-hazard analysis and communications while documenting each legal determination separately.

Is the U.S. "MDR" the same as the EU MDR?

No. In Europe, MDR means the Medical Device Regulation, while adverse-event and field-action duties sit within EU vigilance. Manufacturers selling in both the United States and Europe need market-specific definitions, thresholds, recipients and clocks, even when one global complaint-handling process supplies the underlying facts.