Usage Examples
- Complaint intake flagged it as MDR-reportable, so the 30-day clock started the day we logged it.
- That one needs a 5-day MDR, not a 30-day report, because we are already committing to remedial action.
- Our written MDR procedure has not been revised since we moved to electronic submission, and the auditor noticed.
What is MDR (Medical Device Reporting)?
MDR (Medical Device Reporting) is the FDA post-market surveillance regime requiring manufacturers, importers, and device user facilities to report device-related deaths, serious injuries, and specified malfunctions to FDA on fixed deadlines.
MDR exists because FDA cannot see how a cleared or approved device behaves once it is in hospitals and homes. Pre-market review tests a device under controlled conditions; failures in real use surface later, unevenly, and only the firms and facilities that touch the device see them first. MDR forces that information to FDA on a clock instead of leaving it in company files.
MDR reaches device user facilities, manufacturers, importers, and distributors, with the reporting duties falling on the first three. MDR is triggered when a device may have caused or contributed to a death or serious injury, or when it malfunctions in a way likely to cause that outcome if the malfunction recurred. MDR does not cover routine complaints, drug adverse events, or market authorisation.
MDR is applied through complaint handling. A complaint arrives, someone makes a reportability decision against the Part 803 triggers, and if the event is reportable the clock already started on the day awareness occurred, not on the day the decision was made. MDR reports from manufacturers and importers go to FDA electronically, and the written MDR procedure governing that flow is itself inspectable.
Not to be confused with
- EU MDR (Medical Device Regulation)
- In Europe the abbreviation MDR normally means the EU Medical Device Regulation, a market-authorisation framework that decides whether a device may be placed on the market. MDR under 21 CFR Part 803 is a US post-market reporting duty and confers no marketing authorisation at all.
- Adverse event
- An adverse event is the occurrence itself. MDR is the narrower legal obligation to report a defined subset of those occurrences to FDA within a fixed number of days. Most adverse events never become MDR reports, and the reportability decision is the regulated step.
- Complaint
- A complaint is any allegation about device quality, safety, or performance logged in the quality system. MDR is the subset of complaints that meets a Part 803 trigger. Every MDR starts as a complaint; the reverse is false, and conflating the two produces both over-reporting and late reporting.
- Recall or correction and removal reporting
- A recall is a corrective action taken on marketed product. MDR is a report about an event. Filing an MDR does not discharge recall reporting obligations, and conducting a recall does not remove the MDR duty for the underlying event.
MDR obligations differ by reporter type. These are the anchors in 21 CFR Part 803.
What you must do
- 1Report to FDA any event in which your device may have caused or contributed to a death or serious injury, or malfunctioned in a way likely to cause or contribute to one if the malfunction recurred, no later than 30 calendar days after the day you receive or otherwise become aware of the information21 CFR 803.50(a)
- 2Submit a 5-work-day report when an MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health21 CFR 803.53(a)
- 3As a device user facility, report no later than 10 work days after the day you become aware of the information: deaths to FDA and to the device manufacturer, serious injuries to the manufacturer, or to FDA where the manufacturer is unknown21 CFR 803.30(a)
- 4Submit manufacturer and importer initial, supplemental, and follow-up reports to FDA in an electronic format that FDA can process, review, and archive21 CFR 803.12(a)
- 5Develop, maintain, and implement written MDR procedures covering the internal systems for timely and effective identification, communication, and evaluation of events that may be subject to MDR21 CFR 803.17
Common mistakes
Starting the 30-day clock when the investigation closes
21 CFR 803.50(a) runs from the day you receive or otherwise become aware of the information, not the day you conclude the event is reportable. Firms that wait for a completed complaint investigation file late on events they ultimately reported correctly on the merits, converting a clean safety record into a reporting violation.
Treating an unreproducible failure as non-reportable
The malfunction trigger is conditional, not confirmed: the question is whether this device or a similar one you market would be likely to cause or contribute to a death or serious injury if the malfunction recurred. "We could not reproduce it" is a test result, not a reportability decision, and the rationale for not reporting has to be documented either way.
Reporting correctly with no written MDR procedure
21 CFR 803.17 makes the procedure itself the obligation. A firm whose individual reports are all timely still has a documented failure if it cannot show the written procedure governing identification, communication, and evaluation of reportable events, because an inspector tests the system, not just the last twelve reports.
When This Matters
- Complaint intake flagged it as MDR-reportable, so the 30-day clock started the day we logged it.
- That one needs a 5-day MDR, not a 30-day report, because we are already committing to remedial action.
- Our written MDR procedure has not been revised since we moved to electronic submission, and the auditor noticed.
Frequently Asked Questions
Manufacturers have 30 calendar days from the day they receive or otherwise become aware of information about a reportable death, serious injury, or malfunction (21 CFR 803.50). Device user facilities have 10 work days (21 CFR 803.30). A 5-work-day report is required when the event necessitates remedial action to prevent an unreasonable risk of substantial harm (21 CFR 803.53).
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