United States (FDA)
21 CFR Part 803: Medical Device Reporting
Medical Device Reporting (MDR) is how FDA learns about deaths, serious injuries and certain malfunctions involving marketed devices. For manufacturers, the regulation reaches straight into complaint handling: every complaint needs an MDR decision, and the reasoning behind that decision is something investigators read closely.
At a Glance
- Regulation
- 21 CFR Part 803
- Subject
- Medical Device Reporting
- Group
- United States (FDA)
- Industries
- 12 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
Part 803 sets reporting requirements for three groups. Manufacturers report deaths, serious injuries and malfunctions that would be likely to cause or contribute to a death or serious injury if they were to recur. Importers report deaths and serious injuries to FDA and the manufacturer, and malfunctions to the manufacturer. Device user facilities, such as hospitals and nursing homes, report deaths to FDA and the manufacturer and serious injuries to the manufacturer. The regulation sets reporting timeframes, which differ by event type and reporter, and manufacturers and importers submit reports electronically.
A reporting obligation is triggered when the firm becomes aware of information that reasonably suggests a reportable event occurred. That makes the intake and evaluation of complaints the real control point. Information from service calls, sales representatives, literature, social media and returned product can all start the clock, which is why MDR is tightly linked to complaint files under the QMSR.
The regulation also requires written MDR procedures covering how events are identified, evaluated and reported on time, plus MDR event files that document the information considered and the reasoning for each reportability decision, including decisions not to report. Medical Device Reporting is one of the other applicable FDA requirements named in Compliance Program 7382.850, so it is reviewed during routine QMS inspections.
Who It Applies To
- Manufacturers of devices marketed in the United States, including foreign manufacturers
- Importers of devices into the United States
- Device user facilities such as hospitals, ambulatory surgical facilities, nursing homes and outpatient diagnostic facilities
- Contract manufacturers and specification developers, depending on who holds the manufacturer role for a device
What Auditors Check
Written MDR Procedures
Procedures that define how the firm identifies reportable events, who evaluates them, how reports are submitted on time, and how event files are kept.
Complaint to MDR Decision Trail
Investigators sample complaints and check that each one received a documented MDR evaluation, and that the conclusion follows from the facts in the file.
Decisions Not to Report
The rationale behind non-reported events gets particular scrutiny, especially for malfunctions and for events where a serious injury was possible.
Timeliness
Whether reports were filed within the timeframes the regulation sets, measured from when the firm first became aware, not from when the complaint was logged.
Awareness Across the Business
Whether service, sales and customer support route event information into complaint handling promptly, so the firm's awareness date is not missed.
Follow-Up and Supplemental Reports
Whether new information after an initial report was evaluated and submitted as needed, and whether investigation results were captured in the event file.
Related Services
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference 21 CFR Part 803
- Class I Device Manufacturers
- Class II Device Manufacturers
- Class III Device Manufacturers
- Combination Products
- Implantable Devices
- Cardiovascular Devices
- Ophthalmic Devices
- Medical Supply Manufacturers
- Durable Medical and Home-Use Equipment
- Distributors and Importers
- Reprocessors, Refurbishers and Servicers
- Specification Developers
Questions
Does every complaint need an MDR evaluation?
Every complaint should be evaluated to decide whether it is an MDR reportable event, and that decision should be documented. Many complaints won't be reportable, but investigators expect to see that the question was asked and answered with a reason. Missing or one-line evaluations are a common source of observations.
What makes a malfunction reportable?
A manufacturer reports a malfunction when the device failed to meet its performance specifications or perform as intended, and a recurrence would be likely to cause or contribute to a death or serious injury. The judgment depends on the device and its use, so the reasoning in the event file matters.
How long do we have to file a report?
The regulation sets reporting timeframes that differ by event type and by reporter, and the clock starts when the firm becomes aware of the reportable information. Your MDR procedure should state the timeframes that apply to you and how the awareness date is captured. Check the current text of Part 803 for the specific requirements.
How does QMSAdvisor help with MDR readiness?
We review your MDR procedure and sample complaint files against it, looking for missing evaluations, weak rationales and timing gaps. Findings go into your action plan with owners, due dates and the evidence an advisor needs to close them. The FDA Inspection Simulator can also include MDR requests in a practice inspection.
21 CFR Part 803
Check Your Quality System Against 21 CFR Part 803
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
