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MEDICAL DEVICES


ADVERSE EVENTS REPORTING

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report significant medical device adverse events to the Food and Drug Administration (FDA).

There is also a voluntary MedWatch program for consumers or healthcare professionals to use to voluntarily report significant adverse events or product problems with medical products to FDA.

MDR Mandatory Reporting requirements

The MDR regulation provides a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. There are specific requirements for manufacturers, importers and user facilities.

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: User Facilities (e.g., hospitals, nursing homes) are required to report a suspected medical device-related death to both the FDA and the manufacturer. User facilities should report a medical device-related serious injury only to the manufacturer. If the medical device manufacturer is unknown, the user facility should report the serious injury to FDA. A user facility is not required by the MDR regulation to report a malfunction, but can use the voluntary MedWatch program to advise FDA of problems with medical devices.

Voluntary MedWatch Reporting program

The second reporting mechanism, voluntary reporting by healthcare professionals, is just as vital as mandatory MDR in protecting the safety of patients and device operators.

Under MedWatch, FDA’s Medical Products Reporting Program, health professionals are encouraged to report serious adverse events and product problems. Whenever a device fails to perform as expected, it should be kept, as well as any other material evidence that could be used if an investigation of the product is made.

FDA is also interested in reports of product problems such as inaccurate or unreadable labeling, packaging or product mix-up, contamination or stability problems, defective devices, or product confusion (caused by name, labeling, design, or packaging).

The Voluntary System can be used for reporting medical device events occurring in clinical settings which are exempt from user facility reporting (such as the office of a physician, nurse practitioner, or dentist). Events that are particularly important to report are serious device malfunctions that result in a death or injury, or when a device-related condition is created that may be unsafe, hazardous, or otherwise presents a public health concern.

MEDERA Consulting can assist you with assessing the need for adverse event reporting and file your reports as well as communication and follow-up with the FDA. To obtain a free assessment of your particular situation simply contact us.

To find out more about our regulatory consulting services access the following link for a free copy of our white paper on marketing a healthcare product in U.S. Please click here.