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 characteristics or performance of a 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  incident that directly or indirectly led to, might have led to, or might lead to any of the following:

• the death of a patient, user, or another person

• the temporary or permanent serious deterioration of a patient's, user's, or another person's state of health

• a serious public health threat

Serious incidents involving medical devices on 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? 

Report on Melde.no

Learn more about mandatory reporting of serious incidents in healthcare facilities

What are field safety corrective actions and field safety notices?

Corrective Actions

A corrective action is any action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation related to a medical device.

Field Safety Corrective Actions

A field safety corrective action is any corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident related to a device made available on the market

Field Safety Notice

A field safety notice is a communication issued from the manufacturer to inform users and owners about a field safety corrective action. The notice must describe how the corrective action is to be carried out.

Only field safety corrective actions and the related field safety notice concerning medical devices in Norway should be reported to NoMA.

Information about serious incidents and field safety corrective actions helps ensure that medical devices on the Norwegian market is safe to use.