Incidents involving medical devices

Incident reports of medical devices play an important safety role. All those who manufacture, sell, distribute, own, or use medical devices and are aware of incidents, deviations, defects, or malfunctions that could cause or have caused health damage or death to the user are required to report such to the Icelandic Medicines Agency. Those conducting clinical research on medical devices must also report all serious adverse events (SAEs) that occur during testing. When the Icelandic Medicines Agency receives incident reports regarding medical devices, the incident is recorded and assessed as appropriate.

Healthcare professionals, users, and patients are encouraged to report any suspected incidents.

If it is found that a device does not comply with the requirements of the Icelandic Medicines Agency, and/or is considered that the device poses a serious risk when used, the agency may take action, such as withdrawing or recalling the device in question, as provided by law.

Delivery

Comments from the Icelandic Medicines Agency, if any, will be received within five weeks of receiving the notification. Otherwise, the case will be closed by the Icelandic Medicines Agency.

Cost

There is no cost to submit an incident report.