Medical Devices

The IMA is responsible for regulatory surveillance of medical devices. The goal of this surveillance is to ensure the safety and quality of devices and to protect patients.

The current legislation for medical devices places obligations on manufacturers to ensure that their devices are safe and fit for intended purpose before they are CE marked and placed on the market.

CE marking

This 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. 

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Medical Device Registration

The Icelandic Medicines Agency shall maintain a register of parties operating enterprises in Iceland which manufacture medical devices or are responsible for the marketing of such devices.

The registration form is available here

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Incident Report for Medical Devices

Adverse 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.

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Law and regulation on Medical Devices

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.

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