Helping Sponsors With Fast and Accurate Medical Device Reporting (MDR)
Medical Device Reporting (MDR) regulations mandates manufacturers, importers, device user facilities such as hospitals, nursing homes and outpatient healtcare offices to timely report all medical device related adverse events and product problems as part of post-market surveillance.
In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety. FDA analyzes all reported MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
As an experienced MedTech service provider, our team has extensive knowledge of applicable international regulations and standards (MDD 93/42/EEC, 13485 and MDR).
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Summary of Mandatory Reporting Requirements for Manufacturers and Importers
|REPORTER||WHAT TO REPORT||REPORT FORM #||TO WHOM||WHEN|
|Manufacturers||30 day reports of deaths, serious injuries and malfunctions||Form FDA 3500A *||FDA||Within 30 calendar days of becoming aware of an event|
|5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health||Form FDA 3500A *||FDA||Within 5 work days of becoming aware of an event|
|Importers||Reports of deaths and serious injuries||Form FDA 3500A *||FDA and the manufacturer||Within 30 calendar days of becoming aware of an event|
|Reports of malfunctions||Form FDA 3500A *||Manufacturer||Within 30 calendar days of becoming aware of an event|
Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.
Although a user facility is not required to report a device malfunction, they can voluntarily inform the FDA of such product problems through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.