When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event per regulatory guidelines. These guidelines vary depending on the market that the device is being sold. If a device is being sold in multiple markets the manufacturer will have to keep the reporting requirements for all markets in mind when dealing with an adverse event. These slight differences are incredibly important to keep track of. Even what an adverse event is called might be different, for example in the European Union an adverse event is referred to as a serious incident. Even more important is that when an adverse event is identified there are strict timelines that must be followed for reporting the event to the relevant authorities.
The FDA has 2 different reporting requirements depending on the event that occurs. Serious injuries or malfunctions must be reported to the FDA via Form FDA 3500A within 30 calendar days of becoming aware of the incident. This means when a manufacturer becomes aware of the event they have 30 days to report it. Additionally, there are special events classified by the FDA, including events that pose an unreasonable risk to public health, that must be reported within 5 working days of becoming aware of the incident.1 Importers are also obligated by the FDA to report adverse events. No matter the event, an importer is obligated to report it within 30 calendar days of becoming aware of the incident.1
The European Union’s requirements are much more strict for their serious incident reporting timelines. A serious incident must be reported within 2 calendar days of becoming aware of the incident if that incident poses a serious threat to public health. Additionally, any incident that results in a death or serious deterioration in someone’s health, temporary or otherwise, must be reported within 10 calendar days of becoming aware of the incident.2 Any other incident must be reported within 15 calendar days after becoming aware of the incident. 2
Having the processes in place to ensure all the reporting timelines are met is incredibly important. Thankfully, EMMA International can help create those processes. EMMA International can also assist with the actual reporting of the events/incidents and implementing any corrective actions needed. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at email@example.com to get in touch with our team of experts today.
 FDA (May 2020) Mandatory Reporting Requirements: Manufacturer, Importers, and Device User Facilities, Retrieved 04/09/2022 from https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities
 Medical Device Regulation ( July 2019) MDR- Article 87 – Reporting of Serious Incidents and Field Safety Corrective Actions, Retrieved 04/09/2022 from https://www.medical-device-regulation.eu/2019/07/16/mdr-article-87-reporting-of-serious-incidents-and-field-safety-corrective-actions/