§803.18. What are the requirements for establishing and maintaining MDR files or records that apply to me? — Inbound Citations

(2) If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if you have information that would lead a person who is qualified to make a medical judgment reasonably to conclude that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers. You must keep in your MDR event files (described in § 803.18) the information that the qualified person used to determine whether or not a device-related event was reportable.

(1) You are a user facility, importer, or manufacturer, and you determine that the information received is erroneous in that a device-related adverse event did not occur. You must retain documentation of these reports in your MDR files for the time periods specified in § 803.18.

(4) Maintain complaint files in accordance with § 803.18; and