MDR (Medical Device Report)

A Medical Device Report (MDR) is a safety report submitted to the FDA's Center for Devices and Radiological Health (CDRH) to notify the agency of adverse events involving medical devices. MDR reporting is required under 21 CFR Part 803 and is a critical component of the FDA's post-market surveillance system.

Note: This MDR (Medical Device Report) is different from the EU MDR (Medical Device Regulation 2017/745).

Who must report:
Medical Device Reports must be submitted by:
- Manufacturers - Device deaths, serious injuries, and malfunctions
- User facilities (hospitals, nursing homes) - Device deaths and serious injuries
- Importers - Device deaths, serious injuries, and malfunctions
- Healthcare professionals and consumers can voluntarily report via MedWatch

Reportable events:
- Death - Event where device may have caused or contributed to death
- Serious injury - Life-threatening injury, permanent impairment, or injury requiring medical intervention
- Malfunction - Device failure that would likely cause death or serious injury if it recurred

MDR reporting timelines:
- 5-day report - Event requiring immediate remedial action
- 30-day report - Deaths, serious injuries, and malfunctions (manufacturers/importers)
- Quarterly reports - Summary of malfunction information
- User facilities: 10 working days for deaths, semi-annual reports for serious injuries

MDR report contents:
- Patient information (when available)
- Device identification and lot/serial numbers
- Event description and timing
- Manufacturer information
- Follow-up actions taken
- Assessment of device role in the event

How to submit MDR reports:
Reports are submitted electronically through the eSubmitter platform or via the FDA's Electronic Medical Device Reporting (eMDR) system. User facilities and importers may also submit via Form FDA 3500A.

FDA use of MDR data:
The FDA analyzes MDR reports to:
- Identify device safety signals
- Track adverse event trends
- Initiate recalls or safety communications
- Support regulatory decisions
- Inform inspections and enforcement

Public access:
MDR reports are available to the public through the FDA's MAUDE database (Manufacturer and User Facility Device Experience), allowing researchers, healthcare providers, and consumers to review adverse event data.

Penalties for non-reporting:
Failure to submit required MDR reports can result in Warning Letters, consent decrees, injunctions, or criminal prosecution under the Federal Food, Drug, and Cosmetic Act.