MDR Reportability Decision Checklist

A one-page checklist for deciding whether a medical device complaint is reportable to FDA under 21 CFR 803.

Every complaint your team receives carries the same question: is this an MDR? Miss a reportable event and FDA can cite it. Report too often and your team loses weeks to reports that never needed filing. This checklist puts the decision questions, deadline rules and documentation requirements on one page, so every complaint handler works through the same steps in the same order.

- The eight questions that decide reportability, in the order to ask them
- How to handle malfunctions where nobody was harmed
- When use error ends the assessment, and when it doesn't
- 30-day, 5-day and supplemental report deadlines, with the 21 CFR 803 section for each
- When the reporting clock starts, and why intake delays eat into it
- The records FDA expects in your MDR event files, including decisions not to report

Complaint handlers, quality engineers, regulatory affairs teams and anyone who signs off on MDR decisions at a medical device manufacturer.

Keep it next to your complaint intake process and work through it on every new complaint. Attach the completed checklist to the complaint record, so your reasoning is documented if an auditor or FDA inspector asks how you reached the decision.

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