Maps to
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. MDR event files must contain information in the possession of the user facility, importer, or manufacturer, or references to information, related to the adverse event (MDR event files may incorporate references to other information in lieu of copying and maintaining duplicates in the file), including all documentation of its deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under 21 CFR Part 803; copies of all reports submitted under Part 803 (whether paper or electronic), and of all other information related to the event that it submitted to FDA or other entities such as an importer, distributor, or manufacturer; and copies of all 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.