Medical Device Registration and Approval in Iceland

General country-specific regulatory information is provided on this page for medical device registration and approval in Iceland. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Iceland, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Iceland

REGULATORY AUTHORITY: Medical devices are regulated by the Icelandic Medicines Agency (IMA). Although Iceland is not a member of the European Union (EU), it is a signatory to the European Economic Area agreement. Devices can only be marketed and sold in Iceland if they already have a CE Mark.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the EU or EEA is required.

Last updated on March 17 2015.

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