Medical Devices

Medical Device Reporting(MDR)

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

Usage Examples

The device failure required an MDR within 30 days.
MDR trend analysis identified a design issue.
The manufacturer submitted 5-day MDR for the death report.

What is MDR?

Medical Device Reporting (MDR) requires manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to FDA. This supports FDA's post-market surveillance of device safety.

Manufacturers must report events where the device may have caused or contributed to death (within 30 days) or serious injury (within 30 days), or any malfunction that could cause death or serious injury if recurred. User facilities report deaths to FDA and manufacturers, injuries to manufacturers.

MDR reports are submitted through FDA's electronic submission system (eMDR). Reports are made public in the MAUDE database.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 803.

FDA CDRHEMAHealth Canada

When This Matters

The device failure required an MDR within 30 days.
MDR trend analysis identified a design issue.
The manufacturer submitted 5-day MDR for the death report.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 803

Frequently Asked Questions

Five-day reports are required for events requiring remedial action to prevent unreasonable risk, or events for which FDA has requested 5-day reporting.

A malfunction report is required when a device fails to meet specifications and could cause death or serious injury if the malfunction recurred in a similar device on the market.