Medical Device Reporting (MDR)

The Medical Device Reporting (MDR) regulations under 21 CFR Part 803 require medical device companies to notify the FDA of problems with their products and certain categories of adverse-device events. 

Regulatory authorities focus more on risk mitigation and the post-market monitoring of medical devices as these products continue to evolve within the medical device industry. As a result, continued emphasis will be placed upon shifting a portion of the burden to perform post-market surveillance and to provide appropriate reports to regulatory agencies onto the manufacturers of medical devices. The FDA systematically released updated regulations on MDR requirements that became effective in 2016 that dictate the actions needed by device manufacturers, importers and device user facilities to meet their reporting responsibilities for device-related adverse events.  

Medical Device Reporting Requirements

Each type of reporting entity has distinct and different reporting requirements regarding medical device adverse events. The MAUDE database (Manufacturer and User Facility Device Experience) includes mandatory medical device reporting records from manufacturers and importers of medical devices since August 1996 and can be accessed from the FDA website. The key FDA medical device reporting requirements are as follows: 

Manufacturers - The FDA requires medical device manufacturers to submit reports anytime they learn of the possibility that their device contributed to someone dying as a result of using the medical device or serious injury resulting from the use of the device or device malfunction and they also need to file reports anytime they learn that a malfunctioning device could cause serious injury or death to someone using the medical device. 

Importers - When an importer learns that an imported device may have contributed to someone dying, the importer must report the information to the FDA. However, when the importer learns of an imported device that may malfunction and cause serious injury or death to someone using the medical device, the importer is only required to report the device malfunction to the device manufacturer, they are not required to submit their report directly to the FDA. The medical manufacturer is responsible for forwarding the report of the malfunctioning medical device to the FDA as required. 

Device User Facilities - Device user facilities include hospitals, out-patient surgery centers, nursing homes, physicians’ offices and any other facility where medical devices are used. Examples of all these facility types include any location or context in which Medical Devices are used routinely. Medical device user facilities are required to report any suspected device related deaths to the device manufacturer and to the FDA. If a medical device is suspected to have caused a serious injury, it must be reported to the manufacturer, or to the FDA if the manufacturer cannot be readily identified. 

The FDA sets out different reporting requirements for manufacturers, device importers, and device user facilities when it comes to submitting adverse event reports in a timely fashion.