The short answer
Under 21 CFR part 803, medical device manufacturers — including foreign manufacturers whose devices are sold in the U.S. — must report to FDA when they learn that a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would be likely to cause one if it happened again. The deadline is 30 calendar days, or 5 work days in urgent cases. Reports go to FDA electronically (eMDR).
Who reports what
| Who | Event | Deadline | To whom |
|---|---|---|---|
| Manufacturer | Death, serious injury or reportable malfunction | 30 calendar days | FDA |
| Manufacturer | Event needing remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA asks in writing | 5 work days | FDA |
| Importer | Death or serious injury | 30 calendar days | FDA and the manufacturer |
| Importer | Reportable malfunction | 30 calendar days | The manufacturer |
The clock starts when anyone in your company becomes aware of information that reasonably suggests a reportable event — from a complaint, a distributor, a service report or a news article.
What you must have in place
- 1Written MDR proceduresRequired by 21 CFR 803.17: how you identify and evaluate events, decide if they are reportable, submit on time and document it.
- 2eMDR set-upSince August 14, 2015, MDRs must be submitted electronically (final rule of February 14, 2014). Set up an account before you need it.
- 3Complaint handling linked to MDREvery complaint is checked for reportability; your QMSR complaint files and MDR files should match. See QMSR.
- 4MDR event filesKept for 2 years from the event or for the expected life of the device, whichever is longer.
- 5Agreements with importers and distributorsSo U.S. complaints reach you within days, not weeks.
Example: a blood pressure monitor maker in Taiwan
A Taiwanese maker learns from its U.S. distributor on March 3 that a monitor overheated and burned a user’s arm, needing medical treatment. That is a serious injury. Its MDR procedure flags it the same day, and it files an eMDR well before the 30-day deadline (April 2). When it finds a battery defect that could affect a whole lot and plans a field correction, it also files a 5-day report.
Medical device registration and U.S. Agent $550 per year (FDA user fee separate). Device listing $50 per device. Medical device label review $550.
Frequently asked questions
Do foreign medical device manufacturers have to file MDRs?
Yes. Manufacturers whose devices are sold in the U.S. must report deaths, serious injuries and reportable malfunctions, wherever they are located.
What is the MDR reporting deadline?
30 calendar days for most reports, and 5 work days when remedial action is needed to prevent an unreasonable risk of substantial harm or FDA requests it.
Can MDRs be submitted on paper?
No. Since August 14, 2015, manufacturers and importers must submit MDRs electronically.
How long must MDR files be kept?
2 years from the event or the expected life of the device, whichever is longer.
Sources
- 21 CFR part 803 — Medical device reporting
- Federal Register — Medical device reporting: electronic submission requirements (February 14, 2014)
Requirements checked on November 12, 2026. This article is general information, not legal advice.