MDR (Medical Device Report)
Medical Device Report
MDR (Medical Device Report) (Medical Device Report) is a mandatory report submitted to the FDA under 21 CFR Part 803 when a medical device may have caused or contributed to a death, serious injury, or experienced a malfunction that would be likely to cause or contribute to a death or serious injury if it were to recur.
Complete Guide to 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.
Related Terms
More Clinical & Post-Market
View allAny undesirable experience associated with the use of a medical device, including patient harm, injury, malfunction, or near-miss incidents that must be reported to regulatory authorities.
A systematic evaluation comparing the clinical benefits of a medical device against its risks to determine acceptability for intended use.
A comprehensive document required under EU MDR that evaluates and documents clinical data to demonstrate a medical device's safety and performance.
A systematic study conducted on human subjects to assess the safety and performance of a medical device, required under EU regulations for certain devices before CE marking.
Need Help with USA Registration?
Pure Global provides regulatory consulting and AI-powered tools to help medical device companies navigate USA market access.