Medical Devices
Medical Devices
IMA monitors and ensures compliance with medical device legislation in Iceland. The goal of the surveillance is to prevent patient harm and to ensure that production, maintenance and use of medical devices is according to latest standards and guidelines.
In this section information about the three main EU directives regulating medical devices can be found as well as the Icelandic regulations. All three directives are currently being revised.
CE markingThis section covers the CE marking, its meaning and role in the European Economic Area (EEA). All medical devices with few notable exceptions should bear the CE mark before they are marketed in Iceland.
Incident Report for Medical DevicesAdverse incidents for medical devices should be reported to the IMA. The information from these reports can help the IMA take corrective action and prevent similar incidents from happening again.
The general rule is that instructions for use shall be in Icelandic
