FDA Medical Device Reporting (MDR) Consulting

FDA MDR Reporting Requirements for Medical Device Manufacturers

Manufacturers, importers, and user facilities are mandatory reporters of medical device problems. However, the manufacturer is primarily responsible for reporting events involving their device to the US FDA. “Medical Device Reporting for Manufacturers” outlines MDR obligations in detail, but here is an overview of key FDA MDR requirements:

What Triggers an FDA MDR Report

When manufacturers receive a complaint of a potential adverse event report, they must assess whether an event:

• Resulted in death or serious injury (or may have contributed to that outcome), or

• Involved a malfunction that could cause harm if it recurred

If there's uncertainty, the FDA expects manufacturers to err on the side of reporting.

Reporting Timeframes

Adverse events must be reported within 30 calendar days after becoming aware of the event or within 5 business days if the event requires prompt remedial action to protect public health or if FDA requests it.

What You Must Report

Manufacturers and importers are required to use the FDA’s Electronic Medical Device Reporting (eMDR) system to submit an adverse event report. Submissions route through the FDA’s Electronic Submissions Gateway (ESG), which securely receives and processes all electronic MDR files. Mandatory and voluntary MDR reports are publicly available in the MAUDE database.

Reports must include:

• Complete patient and device information.

• A clear narrative of what happened.

• Details on outcomes, investigation, and corrective actions.

• Any missing information (explain what isn’t available and why)

Submit supplemental MDRs within 30 days if new or corrected information arises. Make sure to reference the original MDR report number.

FDA MDR Record-Keeping Requirements as part of your QMS(R)

Under 21 CFR 803.18, manufacturers must establish and maintain written MDR procedures for identifying and evaluating adverse events, determining reportability, ensuring timely submission of MDRs, and maintaining MDR event files as part of your quality management system (QMS). MDR event files must document every adverse event, including your internal investigation notes, decisions on reportability, and all related correspondence. These files must contain copies of submitted MDR forms and electronic acknowledgments, and should link to relevant records like medical, engineering, or complaint files, testing or customer communication.