MEDICAL DEVICE REGISTRATION AND APPROVAL IN Iceland

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 update: December 2022

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: BelarusBosnia & HerzegovinaLiechtensteinMacedoniaMoldovaNorwaySerbiaSwitzerlandTurkeyUkraine

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?