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21 CFR Part 803 (MDR) §803.18

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21 CFR Part 803 (MDR): §803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?

ISO 13485: §8.2.3 Reporting to regulatory authorities

Requirement text

User facilities, importers, and manufacturers must establish and maintain MDR event files for each adverse event, clearly identified and accessible. Files must contain all information related to the event including documentation of deliberations and decision-making used to determine reportability, copies of all reports submitted, and electronic acknowledgments FDA sends in response to electronic MDR submissions. Manufacturers and importers must retain MDR event files for 2 years from the event date or the expected life of the device, whichever is greater.

21 CFR § 803.18 — current eCFR →

Related clauses

MDR Reporting Requirements — General ObligationsWritten MDR ProceduresManufacturer MDR Reporting — Adverse Event Investigation and Submission5-Day Expedited MDR ReportsReports of Corrections and RemovalsRecords of Corrections and Removals Not Required to Be Reported

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