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.
Last updated on November 24th, 2021.
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.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
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