Iceland medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• No national device registration and no import licence: Lyfjastofnun keeps no register of individual medical devices, and a device that is lawful on the European market and in Iceland may be imported and distributed without a national permit. Iceland operates no import licence, no establishment permit and no device-by-device customs clearance.
• An authorised representative established in the EEA — 'viðurkenndur fulltrúi' — is required where the manufacturer is not established in the EEA; Act 132/2020 defines the role as a natural or legal person established in the European Economic Area holding a written mandate from the manufacturer.
• Distributors must be registered with Lyfjastofnun under 3. mgr. 28. gr. laga um lækningatæki nr. 132/2020. The registration charge is ISK 53,400 (item 2.1 of gjaldskrá nr. 1529/2025) with a separate ISK 26,700 maintenance charge (item 2.2).
• Manufacturers of devices other than custom-made devices, authorised representatives and importers must register in the electronic operator-registration system under Chapter III of the Regulations; this registers the operator, not the device.
• Icelandic-language labelling and instructions: reglugerð nr. 630/2022 Article 3 requires information and instructions for use intended for the general public to be in Icelandic, while a Class I or IIa device may carry English or a Nordic language other than Finnish; for professional use the instructions may be in English or a Nordic language other than Finnish.
• EUDAMED actor and device registration as given effect in Iceland by reglugerð nr. 907/2022; the agency's EUDAMED page has not been updated since 21 October 2021 and still describes registration as not yet obligatory, which disagrees with the regulation.
• Six months' notice to Lyfjastofnun, and to the distributors concerned, before an interruption or discontinuation of supply that could lead to serious harm or a shortage — 36. gr. b of Act 132/2020, inserted by lög nr. 69/2025.
• Vigilance: a manufacturer that learns a device of its manufacture may have caused or has caused an incident must send an initial report to Lyfjastofnun within the Regulation's time limits — immediately for a serious public-health threat, within 2 days for death or serious deterioration, within 10 days for other serious incidents — and anyone who produces, sells, owns or uses devices must report a deviation, defect or malfunction without delay.
• Devices emitting ionizing radiation additionally need a licence from Geislavarnir ríkisins under 7. gr. laga nr. 44/2002 for their use in Iceland, with periodic inspection paid for under 19. gr.
• Devices that are legal measuring instruments additionally need conformity assessment before first use and löggilding by or under HMS under lög nr. 91/2006, at a löggildingargjald of 15-25% of the service fee.
• Radio equipment, including a radio-capable device, must comply with reglugerð nr. 944/2019 and bear CE marking to be placed on the market or taken into use in Iceland; Fjarskiptastofa is the market-surveillance authority and the information for Icelandic users must be in Icelandic, English or a Nordic language other than Finnish.
• Electrically powered equipment placed on the Icelandic market is subject to the úrvinnslugjald under reglugerð nr. 442/2015, 6. gr. 2. mgr., unless the manufacturer and importer pay it; producer responsibility for the waste stream is administered by Úrvinnslusjóður.
• Administrative decisions under the Medical Devices Act may be appealed to the Minister of Health under the Icelandic Public Administration Act, unless the Act provides otherwise.

Reviewed 2026-09-16. End-to-end totals remain planning estimates.