Every year FDA receives thousands of reports of deaths associated with medical devices, serious injuries and device faults. Medical Device Reporting (MDR) is one of the monitoring tool that FDA uses to check the device performance, to find device –related safety issues and contribute to risk and benefit assessment of medical devices.
Who needs to report?
Manufacturers: Manufacturers are required to report to FDA when they find any of their devices may have caused or contributed to a death or serious injury and device malfunction. They must also report if there is any death or serious injury if the malfunction were to recur.
Importers: Importers are required to report to FDA and the manufacturer as soon as they find out that one of their devices may have caused to contribute to a death or serious injury. However the importer must report only to the manufacturer if their imported devices have malfunctioned and would likely to cause death or serious injury if the malfunction were to recur.
Device User Facilities: A “device user facility” is a hospital, nursing home, ambulatory surgical facility, outpatient diagnostic or treatment facility (not a physician’s office). User facilities are required to report to both FDA and the manufacturer. If the manufacturer is unknown, user facilities are required to report only to FDA if there is any medical device related injury or death. User facilities are not required to report any device malfunction but can voluntarily report to FDA by using MedWatch through Electronic Medical Device Reporting (eMDR)
Voluntary Medical Device Reporting: FDA urges healthcare professionals, patients, caregivers and consumers to submit voluntary reports if there is any significant adverse events or device malfunction through MedWatch program.
Liberty Management Group Ltd, is a leading US FDA consulting group provides assistance with food, drug, medical device and cosmetic registration and US Agent service to foreign facilities.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us