Medical Device Reporting

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

MDR Mandatory Reporting Requirements:

Manufacturers: Manufacturers are required to report to FDA when they learn one of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to FDA when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction happened again.

Importers: Importers are required to report to 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 when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to happen again.

User Facilities and MDR

• User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers.
• User facilities report medical device related serious injuries only to the manufacturer.
• If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA.
• Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

Forms and Instructions

• VOLUNTARY MedWatch Reporting for Health Professionals and Consumers (Form FDA 3500)
• MANDATORY MedWatch Reporting for User Facilities, Importers and Manufacturers (Form FDA 3500A)
• Form 3419 Annual User Facility Report