Quick reference on Medical Device Reporting Timelines

Once the company became aware of reportable incident the clock starts. If a death or serious injury has occurred it has to be reported between 2 and 10 calendar days (refer below table). Less serious events/incidents can be reported in 15 to 30 calendar days. If there is an incident but unsure if it is reportable, submit a report anyway. It’s important to remember that filing a report on an incident/event is not an admission of either liability or that device caused or contributed to the event. When in doubt, report.

File a report with a medical device Regulatory Authority when:

• A death or serious deterioration of health has occurred.
• A serious public health threat has emerged.
• A sustained negative trend has developed.
• A recall or field safety corrective action (FSCA) has been issued.

Generally, if labeling is sufficient, reporting is not required when:

• There is a very small likelihood of death or serious injury.
• The incident was caused by patient/user error.
• The service life or shelf life of the device was exceeded.
• The side effects were predictable and disclosed.
• A device problem was discovered by the user prior to use.
• The device shutoff or fault mechanism worked as designed.

Medical Device Reporting Timelines in 6 major markets:

• *      European requirements are for the Medical Device Regulation (2017/745).
• **    Japan has specific reporting timelines for incidents involving device malfunctions, breakages, and fault that could lead to serious events.
• ***  Only required if you also sell the same device in this market. Types of reportable events vary by country. The US FDA requires the reporting of all ex-US events but in Brazil, for example, this only applies to “deaths, serious deterioration of health, and counterfeit devices.”