Serious Incidents and Field Safety Corrective Actions

What are incidents and serious incidents?

Incidents

Incidents involving medical devices refer to any malfunction or deterioration in the properties or performance of the device.

This also includes:

• Use errors due to ergonomic features

• Inaccuracies in information provided by the manufacturer

• Undesirable side effects (MDR - Medical Device Regulation)

• Harm resulting from a medical decision and actions taken or not taken based on the information or results provided by the device (IVDR - In Vitro Diagnostic Regulation)

Serious Incidents

A serious incident is defined as any event that has directly or indirectly led to, could have led to, or may lead to any of the following:

• Death of a patient, user, or another person

• Temporary or permanent severe deterioration in a patient's, user's, or another person's health condition

• Serious public health threat

Serious incidents involving medical devices in the Norwegian market must be reported to the Norwegian Medical Products Agency (NoMA).

Mandatory reporting for healthcare facilities

Healthcare facilities are obligated to report serious incidents that are or may be related to the use of a medical device.

Do you need to report a serious incident? Use the link below.

Report on Melde.no

Learn more about mandatory reporting of serious incidents in healthcare facilities

What are field safety corrective actions and field safety notifications?

Corrective Actions

An action taken by the manufacturer to eliminate the cause of a potential or actual deviation or any other undesirable situation concerning medical devices.

Field Safety Corrective Actions

A corrective measure implemented by the manufacturer to prevent or reduce the risk of serious incidents when using medical devices.

Field Safety Notice

A notification used by the manufacturer to inform users and owners about a corrective safety measure and describe how the measure should be carried out.

Only corrective safety measures and related safety notifications concerning medical devices in Norway should be reported to NoMA.

Information about serious incidents and field safety corrective actions contributes to ensuring that medical devices in the Norwegian market is safe and secure to use.