Jun 29 2022
The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events such as deaths and serious injuries, and also certain malfunctions involving your medical devices. MDR is for detecting and correcting problems in a timely manner.
The requirements of the MDR regulation are enforced under the authority of the FD&C Act.
civil money penalties
The MDR regulation also includes adverse event reporting and recordkeeping requirements for medical device user facilities (e.g., a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility), importers of medical devices, and medical device distributors.
Manufacturers, including foreign manufacturers, of legally marketed medical devices in the United States are required to :
Submit to FDA for the reports of MDR reportable events2 involving their medical devices [21 CFR 803.10(c) and 803.50]
Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event [21 CFR 803.17]
Establish and maintain complete files for all complaints concerning medical device events [21 CFR 803.18]
Q. What are the reporting requirements that apply to medical device manufacturers?
As a manufacturer of medical devices, you are required to submit reports to the FDA of a reportable death, serious injury, or device malfunction [21 CFR 803.10(c)].
A reportable death, serious injury, or malfunction is based on information a manufacturer receives or otherwise becomes aware of, from any source, which reasonably suggests that one of its marketed devices :
May have caused or contributed to a death or serious injury [21 CFR 803.3 and 803.50]
Malfunctioned and the malfunction of the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur [21 CFR 803.3 and 803.50]
Q. Who is considered to be a manufacturer subject to the reporting requirements of the MDR regulation?
A “manufacturer” is any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure [21 CFR 803.3].
The term includes any manufacturers who :
Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture
Initiates specifications for devices manufactured by a second party for subsequent distribution by the person initiating the specifications
Manufactures components or accessories that are medical devices and that are (1) ready to be used and are intended to be commercially distributed and intended to be used as-is (2) processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.
All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to the MDR regulation
and must submit required reports.
US manufacturers of medical devices that are not cleared or approved in the US,
but are exported to foreign locations, are also subject to the MDR regulation.
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