What are the mandatory MDR requirements for manufacturers and importers?
Manufacturers must report device-associated deaths, serious injuries, and malfunctions to the FDA within 30 calendar days of becoming aware of the event. When the manufacturer takes an action to prevent significant risk of substantial harm to the public, the report is due to the FDA within 5 work days, excluding federal holidays. When a manufacturer receives significant new information on a reported event, the new information must be filed as a supplemental report. This information should reference the original MDR number and must be submitted within 30 calendar days. Manufacturers are also required to file baseline reports with the first MDR report on the device or family of devices, with an annual update when there are changes to the baseline data. These baseline data include basic device identification information, such as brand name, device family designation, model number, catalog number, and any other device identification number, as well as information on the shelf life and expe
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