The guidance outlines the FDA’s interpretation of regulatory requirements under MDR regulation and provides input on what types of reports manufacturers need to file in relation to medical device adverse events. It requires manufacturers to submit reports within 30 days, or five days in certain circumstances, of any adverse events reasonably linked to death or serious injury.

The FDA issued guidance detailing reporting and record-keeping requirements for device-related adverse events and certain medical device malfunctions, per the Medical Device Reporting (MDR) regulation. The MDR regulation provides a mechanism for identifying and monitoring adverse events and requires medical device makers to adhere to certain reporting and record-keeping requirements, including:

  • Submitting MDR reportable events to the FDA;
  • Establishing and implementing procedures to identify and assess medical device events to determine whether the event is MDR reportable; and
  • Establishing and maintaining complete files for all complaints regarding medical device events.

MDR reportable events are defined as events a device maker becomes aware of that reasonably indicate a marketed device may have caused or contributed to death or serious injury, or may have malfunctioned and, as a result, contributed to death or serious injury. The guidance also calls on medical device makers to report user errors, whether they are the sole cause of or a factor contributing to an MDR reportable event, as these often signal underlying issues with device labeling, the user interface or other aspects of device design. 

MDR reportable events need to be reported to the FDA within 30 calendar days of the manufacturer becoming aware of the event. However, there are some instances in which a medical device report needs to be submitted within five days, including:

  • Cases that require remedial action to prevent an unreasonable risk of substantial harm to public health; or
  • Cases in which the FDA makes a written request for a five-day report.

Reports of MDR events must contain all the information in the device maker’s possession or that has been obtained from a user facility, importer or other initial reporter, as well as information obtained by analyzing or testing the device. Separate reports should be submitted for each device involved in a reportable event, even if an adverse event involves multiple suspect devices. Supplemental reports must also be submitted when information not available at the time of the initial report becomes available and would alter any information or conclusions in the original report.

Per the guidance, manufacturers must maintain and implement internal systems that allow for:

  • Timely and effective identification, communication and assessment of events that may be MDR reportable;
  • A standardized review process for ascertaining whether an event is MDR reportable; and
  • Timely transmission of complete reports to the FDA.

The guidance applies to any person who:

  • Repackages or changes the container, wrapper or labeling of a device as part of the device distribution;
  • Initiates specifications for devices made by a second party for subsequent distribution; and
  • Makes components or accessories that are medical devices and are ready to be used and intended to be commercially distributed and used as is, or that are processed by a licensed practitioner or other qualified person to meet the needs of a specific patient.