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Lyfjastofnun · structured requirements

🇮🇸 Iceland medical device regulatory data

Explore the medical device requirements currently available for Iceland, organized by topic and linked to official sources.

45 facts25 dimensions13 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising must be objective and complete; misleading text, names, trademarks and images are prohibited

advertising.conditions-and-misleading-claims-prohibition
Fact-level verified

Advertising medical devices in Iceland is permitted subject to the limitations in the Regulations and the Act. Advertising must always be presented objectively and give adequate information about the device, its characteristics and its use, and the user or patient must be informed of the potential risks associated with use of the device in accordance with its intended purpose. The Minister may set further rules by regulation, including prohibiting particular advertising methods or advertising of particular classes of device. In labelling, instructions for use, making available, putting into service and advertising it is prohibited to use text, names, trademarks, images or figurative signs that may mislead the user or patient as to the device's intended purpose, safety or performance. Breach of the claims provision carries the penalties under Article 44.

Effective from 2021-05-26

Icelandic. Articles 10 and 11 implement the MDR Article 7 claims rule as national law. Article 11 is listed in Article 44(3) among the provisions whose breach carries fines or up to two years' imprisonment.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Distributor registration is charged as registration plus maintenance registration; no interval or expiry is published

validity.distributor-maintenance-registration
Fact-level verified

The register that a distributor must keep current in Iceland is the distributor register kept by Lyfjastofnun under Article 28(3) of Act No. 132/2020, and Article 39(5) of the Act makes distributor registration a head of charge. Section 2 of gjaldskrá No. 1529/2025 (17 December 2025) prices it in two separate lines: 'Skráningargjald' (registration charge) ISK 53,400 and 'Viðhaldsskráning' (maintenance registration) ISK 26,700, under the heading 'Gjald fyrir skráningu í þessa skrá Lyfjastofnunar og viðhald hennar'. The schedule fixes no interval for the maintenance charge and no expiry date for the registration itself. Lyfjastofnun's guidance adds that a distributor registers with the agency as a supervised operator, that the agency invoices the distributor according to the fee schedule, and that the distributor need not wait for the invoice to begin distributing devices — so registration is a precondition of activity, not a time-limited permit.

Conditions
  • The fee schedule states the two charges but not the period of the maintenance registration; no Icelandic instrument retrieved fixes an interval or an expiry date for distributor registration.
  • The register is of economic operators only; devices themselves are not registered in Iceland.

Effective from 2025-12-17

Lög um lækningatæki 2020, nr. 132, 8. desember (Act No. 132/2020 on Medical Devices), consolidated text with amendments L. 69/2025 and L. 39/2026Rekstur og dreifing lækningatækja (Operation and distribution of medical devices) — operator duties and distributor registration

Icelandic. Verbatim from the PDF of gjaldskrá No. 1529/2025, section 2, retrieved directly on 2026-09-16 (200 application/pdf, 138,031 bytes; 5 pages; the fee table sits on page 2). Act No. 132/2020 Art. 39 verbatim: "Lyfjastofnun er heimilt að taka gjald fyrir: … 5. Skráningu dreifingaraðila, sbr. 3. mgr. 28. gr." Lyfjastofnun's operator page verbatim: "Samkvæmt lögum um lækningatæki eiga dreifingaraðilar lækningatækja að skrá sig hjá Lyfjastofnun. Lyfjastofnun móttekur og skráir dreifingaraðila sem eftirlitsþega í skráningakerfi stofnunarinnar. Lyfjastofnun sendir reikning á dreifingaraðila samkvæmt gjaldskrá Lyfjastofnunar. Dreifingaraðili þarf ekki að bíða eftir reikningi til að geta hafið dreifingu lækningatækja." The bounded claim is only what the quoted table shows — two charges, one for registration and one for its maintenance — and the row states explicitly that no interval is published; the round-204 version was graded partial for the same reason, and the citation is now the fee schedule's own table with a table locator rather than a page locator. Same key reused so the importer refreshes in place.

There is no Icelandic device approval to renew; the only validity period in the chain is the notified-body certificate, valid for up to five years and extendable on application

validity.no-national-approval-to-renew
Fact-level verified

Iceland grants no national approval for a medical device or IVD and Lyfjastofnun keeps no register of individual devices, so there is no Icelandic registration, licence or authorisation with a validity period to renew and no renewing device fee. What carries a validity period is the Union documentation: MDR (EU) 2017/745 and IVDR (EU) 2017/746 have legal force in Iceland under Article 2 of Act No. 132/2020, and Article 56(2) of the MDR (Article 51(2) of the IVDR in identical terms) provides that the certificates issued by notified bodies are valid for the period they indicate, which shall not exceed five years, and that on application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Operator registration is a separate, non-time-limited act: manufacturers, authorised representatives and importers register in the electronic system under Chapter III of the Regulations and Lyfjastofnun confirms the registration and issues a unique registration number (Art. 28(1)-(2) of the Act); distributors register with Lyfjastofnun under rules the agency sets (Art. 28(3)).

Conditions
  • No Icelandic instrument sets a validity period, renewal deadline or renewal fee for placing a device on the Icelandic market; the register that does exist is a register of economic operators, not of devices.
  • The MDR/IVDR apply in Iceland as EEA-incorporated acts (Article 2 of Act No. 132/2020 gives them legal force with the adaptations arising from EEA Joint Committee Decisions No. 288/2019 and 301/2019 of 13 December 2019 and No. 90 of 18 June 2020).
  • The Union transitional regime in Regulation (EU) 2023/607 (extended validity of legacy certificates) is not restated here.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) — OJ L 117, 5.5.2017Lög um lækningatæki 2020, nr. 132, 8. desember (Act No. 132/2020 on Medical Devices), consolidated text with amendments L. 69/2025 and L. 39/2026Rekstur og dreifing lækningatækja (Operation and distribution of medical devices) — operator duties and distributor registration

English source (Union act) with Icelandic supporting sources. Article 56(2) of the MDR is quoted verbatim from the OJ text at the ELI URL; the identical IVDR wording is Article 51(2) of Regulation (EU) 2017/746 ("The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years …"). The national half is proved by Act No. 132/2020: Article 2 ("Lögfesting") — "Ákvæði reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/745 frá 5. apríl 2017 um lækningatæki … og ákvæði reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/746 … skulu hafa lagagildi hér á landi með þeim aðlögunum sem leiðir af ákvörðunum sameiginlegu EES-nefndarinnar nr. 288/2019 og 301/2019 frá 13. desember 2019 og nr. 90 frá 18. júní 2020" [= "The provisions of Regulation (EU) 2017/745 … and of Regulation (EU) 2017/746 … shall have the force of law in this country with the adaptations arising from EEA Joint Committee Decisions No. 288/2019 and 301/2019 of 13 December 2019 and No. 90 of 18 June 2020"], and Article 28 — "Framleiðendur lækningatækja, annarra en sérsmíðaðra tækja, viðurkenndir fulltrúar og innflytjendur skulu skrá sig í rafrænt kerfi samkvæmt nánari fyrirmælum í III. kafla reglugerðanna. Lyfjastofnun staðfestir skráningu skv. 1. mgr. og afhendir framleiðanda, viðurkenndum fulltrúa eða innflytjanda einstakt skráningarnúmer … Dreifingaraðilar skulu skrá sig hjá Lyfjastofnun eftir nánari reglum sem stofnunin setur." The negative half is quoted from the agency itself — Lyfjastofnun's operator page states "Lyfjastofnun heldur ekki skrá yfir einstaka lækningatæki." ["Lyfjastofnun does not keep a register of individual medical devices."]. The round-204 version of this row was assembled from the absence of a registration provision and graded source-backed-partial; the row is now anchored on express text (MDR Art. 56(2) + Act Art. 2) and the agency's own sentence, so it is raised to official-source-verified. The same key is reused so the importer refreshes it in place.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Lyfjastofnun is the competent authority for MDR and IVDR in Iceland

authority.competent-authority-designation
Fact-level verified

Lyfjastofnun (Icelandic Medicines Agency, IMA) is the Icelandic competent authority under Article 101 of Regulation (EU) 2017/745 (MDR) and Article 96 of Regulation (EU) 2017/746 (IVDR). Its statutory functions are to implement the Regulations and the Medical Devices Act, to supervise medical devices, and to open cases and take decisions on its own initiative or on a report or tip-off.

Effective from 2021-05-26

Icelandic. 'Lyfjastofnun er lögbært stjórnvald skv. 101. gr. reglugerðar um lækningatæki og 96. gr. reglugerðar um lækningatæki til sjúkdómsgreiningar í glasi.' The article is numbered 6. gr. in the consolidated Act; the note '1) L. 69/2025, 6. gr.' marks the amending act that last touched it.

Lyfjastofnun carries market surveillance and may prioritise cases

authority.market-surveillance-mandate
Fact-level verified

Lyfjastofnun supervises compliance with the Medical Devices Act and the Regulations, opens cases on its own initiative or on a report concerning device safety, performs market surveillance in accordance with Section 3 of Chapter VII of the Regulations, decides whether a report gives sufficient grounds for investigation, and may rank cases by priority. It may process personal data, including sensitive data on whether a person has received an implant, for supervision purposes.

Effective from 2021-05-26

Icelandic. 'Lyfjastofnun annast markaðseftirlit í samræmi við nánari fyrirmæli í 3. þætti VII. kafla reglugerðanna.'

Notified bodies: Hugverkastofa designates, Lyfjastofnun notifies to EFTA and the Commission

authority.notified-body-designation-split
Fact-level verified

Designation of notified bodies in Iceland is split. The accreditation division of Hugverkastofa (Icelandic Intellectual Property Office) assesses the competence of an applicant and, having obtained the opinion of Lyfjastofnun, designates notified bodies to Lyfjastofnun. Lyfjastofnun then notifies them to the EFTA Surveillance Authority, the European Commission and the other EEA States under Chapter IV of the Regulations.

Effective from 2021-05-26

Icelandic. The authority that assesses candidates is Hugverkastofa Faggildingarsvið (the accreditation division of the Icelandic Intellectual Property Office), not Lyfjastofnun itself — a split that a registration manager should not have to discover at the wrong moment.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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No Icelandic variation procedure: changes to an approved device require the approval of the notified body that issued the certificate

change.no-national-variation-procedure
Fact-level verified

There is no Icelandic variation, amendment or change-notification procedure and no variation fee, because Iceland holds no national device approval; change control is the Union change-control regime, which has legal force in Iceland under Article 2 of Act No. 132/2020. Under MDR Annex IX point 4.10, changes to an approved device require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device; the manufacturer must inform that notified body, which assesses the planned changes and decides whether they require a new conformity assessment under Article 52 or whether they can be addressed by a supplement to the EU technical documentation assessment certificate, which it issues if the changes are approved. The parallel rules are Annex IX point 2.4 (substantial changes to the quality management system or to the device range covered must be notified to the notified body that approved the system; approval takes the form of a supplement to the EU quality management system certificate) and Annex X points 5.1-5.2 (planned changes to an approved type require the approval of the notified body that issued the EU type-examination certificate). In Icelandic law the manufacturer's side of this is Article 21 of Act No. 132/2020 (technical documentation must be kept up to date) and Article 22 (quality management system, risk management system and post-market surveillance system must be established, maintained and updated), and the agency can require information and data under Chapter VII of the Act. The only change-related charge in gjaldskrá No. 1529/2025 is for changes to a clinical investigation (ISK 106,800); there is no device-variation fee line.

Conditions
  • Iceland operates no national variation or change-notification procedure and publishes no variation fee; a change is handled with the notified body under the Union Regulations.
  • The IVDR carries the same rule in Article 51(2) and Annex IX point 4.11 (with the new-conformity-assessment cross-reference to Article 48).
  • Annex IX point 4.10 is the route for a device certified under Annex IX (QMS plus technical documentation assessment); for a type-examination certificate the parallel rule is Annex X point 5.2.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) — OJ L 117, 5.5.2017Lög um lækningatæki 2020, nr. 132, 8. desember (Act No. 132/2020 on Medical Devices), consolidated text with amendments L. 69/2025 and L. 39/2026Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá Lyfjastofnunar fyrir lækningatæki (Fee schedule No. 1529/2025 for medical devices, set under Art. 39 of Act No. 132/2020)

English source (Union act) with Icelandic supporting sources. Annex IX point 4.10 quoted verbatim from the OJ text at the ELI URL. The IVDR counterpart, Annex IX point 4.11, reads the same with "… whether the planned changes require a new conformity assessment in accordance with Article 48 …". In the Icelandic Act: Art. 21 — "Framleiðandi tækja, annarra en sérsmíðaðra tækja, skal taka saman tæknigögn og halda þeim uppfærðum." ["A manufacturer of devices, other than custom-made devices, shall compile technical documentation and keep it up to date."]; Art. 22 — "Framleiðandi tækja, annarra en tækja til prófunar, skal koma á fót, skrá, koma í framkvæmd, viðhalda og uppfæra gæðastjórnunarkerfi, sbr. 10. gr. reglugerðanna. … Framleiðandi skal koma í framkvæmd eftirlitskerfi eftir markaðssetningu lækningatækis og útbúa áætlun í samræmi við VII. kafla reglugerðanna." The absence of a national variation procedure and fee was checked against the whole of Act No. 132/2020 (no variation article) and against all ten sections of gjaldskrá No. 1529/2025 (the only change line is 6.5 "Breytingar á klínískri rannsókn lækningatækja 106.800"). The round-204 version of this row was an assembled negative graded source-backed-partial; it is now anchored on express Union text with an exact locator and the negative rests on the two named national instruments. Same key reused so the importer refreshes in place.

Classification rules

What local class follows from which rules and decisive product facts?

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MDR classes I, IIa, IIb and III per Annex VIII, with classification disputes going to Lyfjastofnun

classification.mdr-risk-classes-and-dispute-route
Fact-level verified

Devices are divided into risk classes I, IIa, IIb and III according to their intended purpose and risk, classified in accordance with Annex VIII of the Regulations. A disagreement between the manufacturer (or its authorised representative) and the notified body concerned on classification is referred to Lyfjastofnun under Chapter V of the Regulations.

Effective from 2021-05-26

Icelandic. 'Tækjum skal skipt í áhættuflokka I, IIa, IIb og III að teknu tilliti til ætlaðs tilgangs tækjanna og áhættu. Flokkunin skal fara fram í samræmi við VIII. viðauka með reglugerðunum.'

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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A clinical investigation requires the permit of Lyfjastofnun and the national bioethics committee

clinical.authorisation-required-from-agency-and-ethics-committee
Fact-level verified

A clinical investigation of a medical device may only be carried out with the permit of Lyfjastofnun and of vísindasiðanefnd (the national bioethics committee). The application is sent to Lyfjastofnun under Chapter VI of the Regulations; the agency and the ethics committee assess it together, and they supervise compliance. Detailed rules on informed consent, recording of adverse events and the coordinated assessment procedure in clinical investigations follow Chapter VI of the Regulations, and the fee for assessing a clinical-investigation application for all classes is ISK 1,161,450.

Effective from 2021-05-26

Icelandic. 'Heimilt er að framkvæma klíníska rannsókn á lækningatæki að fengnu leyfi Lyfjastofnunar og vísindasiðanefndar.' IVD performance studies follow the same article's reference to Annex XIV of the IVDR. The agency's clinical page repeats the requirement and gives the submission route.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition follows MDR Article 2 and extends to Annex XVI products

scope.device-definition-and-annex-xvi-products
Fact-level verified

Iceland's Act applies to medical devices as defined by the Regulations, and Article 3 of the Act extends the scope to the products without an intended medical purpose listed in Annex XVI of the MDR. Lyfjastofnun's own guidance gives the Annex XVI examples as non-corrective contact lenses, substances or items intended for filling under the skin or mucous membrane, and equipment intended to reduce or remove adipose tissue.

Effective from 2021-05-26

Icelandic, agency guidance page (last updated 3 October 2025). 'Vörur sem hafa ekki læknisfræðilegan tilgang en teljast einnig til lækningatækja eru t.d. snertilinsur án sjónleiðréttingar, efni/hlutir ætlaðir til fyllingar undir húð eða slímhúð og búnaður ætlaður til að minnka/fjarlægja fituvef/tattú.' Software with a specific medical purpose is a device; software that only stores, shares, records or performs simple searches is not.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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The dossier Iceland expects is the EU package: CE marking, EU declaration of conformity and MDR Annex I information

dossier.eu-declaration-of-conformity-and-ce-marking-package
Fact-level verified

The documentation that matters for Iceland is the Union package. The manufacturer must issue an EU declaration of conformity under Annex IV of Regulation (EU) 2017/745, and the device must be accompanied by the required information under Annex I Chapter III point 23 of that Regulation, including the manufacturer's name and registered address, the device name, package contents and intended purpose, the batch or serial number, and shelf-life and storage conditions where applicable. Lyfjastofnun's guidance lists these items as examples and states the list is not exhaustive.

Icelandic, agency guidance page (last updated 3 October 2025). '...skal framleiðandi gefa út EB samræmisyfirlýsingu, samkvæmt viðauka IV í reglugerð 745/2017 um lækningatæki (MDR).' and 'Auk CE merkinga skulu öllum lækningatækjum fylgja nauðsynlegar upplýsingar samkvæmt 23.gr. í viðauka I í reglugerð 745/2017 um lækningatæki (MDR).'

No Icelandic dossier is filed with the authority; technical documentation is held by the manufacturer

dossier.no-national-technical-file-filing
Fact-level verified

Iceland has no national dossier submission. The manufacturer (other than of custom-made devices) must draw up technical documentation and keep it up to date; the documentation must allow the conformity of the device with the Act and the Regulations to be assessed and must cover the matters set out in Annexes II and III of the Regulations. The file is kept by the manufacturer, not filed with Lyfjastofnun; the authority's power is to require it to be produced on request. A registration manager therefore does not file a technical file in Iceland.

Effective from 2021-05-26

Icelandic. 'Framleiðandi tækja, annarra en sérsmíðaðra tækja, skal taka saman tæknigögn og halda þeim uppfærðum.' Article 36 of the Act gives Lyfjastofnun the power to demand all information and data needed to demonstrate conformity, which is the production-on-request mechanism in place of filing.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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An authorised representative established anywhere in the EEA is sufficient for Iceland

operators.authorised-representative-eea-not-iceland-only
Fact-level verified

The Icelandic authorised-representative duty is an EEA-wide duty. The Act's definition of 'viðurkenndur fulltrúi' is a natural or legal person established in the European Economic Area who has received a written mandate from a manufacturer established outside the EEA to act on the manufacturer's behalf for specified tasks in relation to the manufacturer's obligations under the Regulations. A mandate given to a representative established in another EEA State therefore satisfies the Icelandic requirement, and Iceland does not require an Iceland-established representative of its own.

Effective from 2021-05-26

Icelandic. '...lögaðili eða einstaklingur með staðfestu á Evrópska efnahagssvæðinu sem hefur fengið samþykkt skriflegt umboð frá framleiðanda sem er staðsettur utan Evrópska efnahagssvæðisins til að koma fram fyrir hönd framleiðandans vegna tilgreindra verkefna...' This is the EEA-adaptation consequence and distinguishes Iceland from non-EEA candidates that do require a national local representative.

Manufacturer, authorised representative, importer and distributor are distinct roles; a non-EEA manufacturer must appoint an authorised representative

operators.roles-and-authorised-representative-duty
Fact-level verified

Act No. 132/2020 defines the operator roles for Iceland. Where the manufacturer of a device is not established within the European Economic Area, the device may only be placed on the EEA market if the manufacturer appoints an authorised representative; the appointment and duties of the authorised representative follow Articles 11 and 12 of the Regulations. The manufacturer must also have at least one person responsible for regulatory compliance with the required knowledge under Article 15 of the Regulations (Art. 23 of the Act).

Effective from 2021-05-26

Icelandic. 'Ef framleiðandi tækis er ekki með staðfestu innan Evrópska efnahagssvæðisins má eingöngu setja lækningatækið á markað á svæðinu ef framleiðandinn tilnefnir viðurkenndan fulltrúa.' Note the trigger for an authorised representative is EEA establishment, not Icelandic establishment: an EU-based authorised representative satisfies Iceland.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Distributor must verify CE marking, manufacturer information, importer compliance and UDI

import.distributor-verification-checklist
Fact-level verified

Before a device is placed on the market or offered on the market, a distributor must verify that: (1) the device bears CE marking and an EU declaration of conformity has been drawn up for it; (2) the device is accompanied by the information the manufacturer provides under Article 10(11) of the Regulations; (3) for imported devices, the importer has met the requirements of Article 13(3) of the Regulations; and (4) the manufacturer has, where applicable, assigned a UDI. The distributor must otherwise meet the obligations in Article 14 of the Regulations.

Effective from 2021-05-26

Icelandic. Note the distributor's check is documentary (verify), not an approval: distribution in Iceland requires no authorisation, only the Article 28(3) registration with Lyfjastofnun.

Importer must verify four things before offering a device on the Icelandic market

import.importer-verification-checklist
Fact-level verified

Before offering a device on the market, an importer must verify that: (1) the device bears CE marking and an EU declaration of conformity has been drawn up for it; (2) the manufacturer is identified and has appointed an authorised representative in accordance with Article 11 of the Regulations; (3) the device is labelled in accordance with the Act and the Regulations and is accompanied by the required instructions for use; and (4) the manufacturer has, where applicable, assigned a UDI. The importer must otherwise meet the obligations set out in Article 13 of the Regulations. An importer may only place on the market devices that comply with the Regulations and the Act.

Effective from 2021-05-26

Icelandic. Article 25(3) of the Act (the importer verification duty) is what the EUDAMED page refers to when it says an importer must have fulfilled '3. mgr. 13. gr. reglugerðanna'. Iceland has no separate establishment permit for importers.

No national import licence or establishment permit; customs is not a device clearance gate

import.no-national-import-licence
Fact-level verified

Iceland operates no import licence, no establishment permit and no device-by-device customs clearance for medical devices. Lyfjastofnun states that importation is conditional only on the device being lawful on the European market and in Iceland, and is otherwise free; and separately that it keeps no register of individual devices. Lyfjastofnun may nonetheless request information and data from other public authorities, including the customs authorities, irrespective of their duty of confidentiality, so customs data is a supervision input rather than a clearance step.

Icelandic, agency guidance page (last updated 3 October 2025) read together with Art. 36 of Act No. 132/2020 (power to require information from other authorities, 'þar á meðal tollyfirvöldum'). The guidance passage is quoted verbatim in the excerpt.

Fees

What regulator fee applies to this class, route, event, and date?

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Fee schedule No. 1529/2025: distributor registration ISK 53,400, maintenance registration ISK 26,700

fees.tariff-instrument-and-distributor-registration-amounts
Fact-level verified

The fees Lyfjastofnun may charge for medical devices are set by the Minister under Article 39 of Act No. 132/2020 in the fee schedule (gjaldskrá). The schedule in force is Gjaldskrá nr. 1529 of 17 December 2025 (in force 1 January 2026, repealing gjaldskrá nr. 1555/2023). Its device articles are: 1. gr. certificates (Free Sales Certificate, five copies, ISK 53,400; each further copy of a device or IVD FSC beyond five, ISK 26,700; other certificates ISK 40,050 per copy); 2. gr. distributor registration (registration ISK 53,400; maintenance registration ISK 26,700); 3. gr. supervision of use (device/IVD ISK 160,200; management system ISK 387,150) and assessment of applications to use a device that does not meet the requirements, in the interest of public health or patient safety (Class IIa and non-invasive Class IIb/III devices ISK 200,250; Class IIb/III including implantable devices, invasive devices for long-term use and IVDs ISK 293,700; other exemptions ISK 200,250); 4. gr. supervision of maintenance (device ISK 200,250; management system ISK 387,150); 5. gr. supervision of operators (market surveillance of distributors/importers ISK 133,500; their quality management ISK 387,150; market surveillance of manufacturers/authorised representatives ISK 133,500; their quality management ISK 774,300); 6. gr. clinical investigations (pre-check ISK 200,250 in both class bands; assessment of a clinical-investigation application, all classes, ISK 1,161,450; approved clinical investigation ISK 387,150; changes ISK 106,800); 7. gr. hourly rate ISK 26,700 per specialist-hour.

Effective from 2025-12-17

Icelandic. Amounts are read verbatim from the schedule PDF published on the agency's own domain; the schedule is set with authority in Article 39 of Act No. 132/2020, whose six charging heads are certificates, supervision of use, supervision of maintenance, assessment of clinical-investigation applications, distributor registration and supervision of operators. Article 7 of the schedule applies an hourly rate for extra work, and the applicant has 14 days to withdraw for a refund.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Implant cards issued to patients must as a rule be in Icelandic

label.implant-card-icelandic
Fact-level verified

Implant cards that health institutions give to patients are as a rule to be in Icelandic. Where that is not possible, the cards may be in English or another Nordic language other than Finnish. The same language requirements apply to the implant information that the manufacturer must publish on its website under Article 18 of Regulation (EU) 2017/745.

Icelandic, agency guidance page (last updated 3 October 2025). 'Ígræðakort sem heilbrigðisstofnanir afhenda sjúklingum eiga að jafnaði að vera á íslensku. Verði því ekki við komið er heimilt að kortin séu á ensku eða öðru Norðurlandamáli, nema finnsku.'

Instructions for use for the general public must be in Icelandic, with a class I/IIa exception

label.lay-use-ifu-icelandic-general-rule
Fact-level verified

Information and instructions for use accompanying medical devices intended for use by the general public must be in Icelandic. However, for a device in risk class I or IIa, the instructions for use may instead be in English or in a Nordic language other than Finnish. Lyfjastofnun may publish on its website a list of types or classes of devices in risk classes IIb and III that are exempt from the Icelandic requirement. Importers must verify that the device is accompanied by the required instructions for use before it is offered on the market.

Effective from 2022-06-01

Icelandic. 'Upplýsingar og notkunarleiðbeiningar með lækningatækjum sem ætluð eru almenningi til notkunar skulu vera á íslensku. Þrátt fyrir ákvæði 3. mgr. er þó heimilt ef um er að ræða lækningatæki í áhættuflokki I og IIa að notkunarleiðbeiningarnar séu á ensku eða Norðurlandamáli öðru en finnsku.' Regulation 630/2022 was set under Art. 12(4) and Art. 48(4) of Act No. 132/2020, entered into force on publication (information panel: first in force 1 June 2022), and repealed Reg. 789/2021.

Professional-use IFU may be English or a Nordic language; the IIb/III exemption list is exhaustive

label.professional-use-and-iiib-iii-exemptions
Fact-level verified

For devices intended for use by professionals, the instructions for use may be in English or in a Nordic language other than Finnish. For devices for lay use the general rule is Icelandic, with class I and IIa permitted in English or a Nordic language other than Finnish; for classes IIb and III Lyfjastofnun may exempt devices by publishing a list, and that list is exhaustive (currently covering condoms in classes IIb and III, last revised 18 November 2022).

Icelandic, agency guidance page (last updated 5 February 2026). The agency states of the IIb/III exemption list 'Listinn er tæmandi' (the list is exhaustive), which is the operative point for a filer: an unlisted class IIb or III lay-use device cannot rely on an English IFU.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Manufacturer must run a post-market surveillance system and supply PMS reports to Lyfjastofnun on request

pms.manufacturer-post-market-surveillance-system-and-reports
Fact-level verified

The manufacturer of a device other than an investigational device must establish, document, implement, maintain and update a quality management system under Article 10 of the Regulations and a risk management system as described in the Regulations. It must operate a post-market surveillance system and draw up a plan in accordance with Chapter VII of the Regulations, and must produce post-market surveillance reports under Chapter VII. The reports must be updated as necessary and supplied to Lyfjastofnun at the agency's request.

Effective from 2021-05-26

Icelandic. The last sentence — 'Skýrslurnar skulu uppfærðar eftir þörfum og afhentar Lyfjastofnun að kröfu stofnunarinnar' — is the Icelandic delta: PMS reports are not routinely filed with Lyfjastofnun, they are produced on request.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Official Lyfjastofnun forms for device duties: incident notifications, distributor registration, CE-marking exemption and clinical investigation

forms.device-forms-index
Fact-level verified

Lyfjastofnun publishes its medical-device forms on one official index. The device forms listed are: notification of an incident involving a medical device (web form); manufacturer's notification of an incident involving a medical device (web form); notification of an incident involving an implantable medical device (docx); notification of a serious incident in a clinical investigation; registration form for distributors (web); application for exemption from CE marking of a medical device (web); and application for a clinical investigation of a medical device. The index page was last updated 14 September 2026.

Icelandic, agency forms index. The three forms a registration manager is most likely to need are the distributor registration form, the CE-marking exemption application and the clinical investigation application; all three are web forms rather than PDFs.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Lyfjastofnun may inspect premises, take samples and seize devices, with a warrant needed for dwellings

inspection.establishment-inspection-and-seizure-powers
Fact-level verified

Lyfjastofnun may enter places where medical devices are located — a manufacturing site, a sales point whether wholesale or retail, or another place where devices are used. It may not enter a dwelling or comparable place for that purpose without the consent of the owner or occupier or a court order. In an inspection or investigation it may take the samples and carry out the examinations and tests it considers necessary, and it may make the necessary examinations at an operator's premises and prohibit continued use, sale and distribution and seize documents or devices where strong grounds exist to believe the Act or the Regulations have been breached.

Effective from 2021-05-26

Icelandic. Note that this inspection power is broader than a QMS audit: it reaches sales points and user sites, not only manufacturers under a notified-body audit. The Act also provides that the police shall assist Lyfjastofnun where necessary for the investigation of cases and enforcement (Art. 34).

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Breaches carry fines or up to two years' imprisonment; daily fines up to ISK 50,000 per day

recall.penalties-and-daily-fines
Fact-level verified

Breach of the Icelandic Act's provisions on, among other things, safety requirements, CE marking, claims, labels and instructions for use, safe handling, user training, clinical investigations, manufacturer duties, manufacturer surveillance, importer duties, distributor duties, registration of implantable devices, and serious-incident notification, carries fines or imprisonment for up to two years unless a heavier penalty applies under other law. Fines may be imposed on a legal person even where no guilt is proven against its representatives or employees. Where a party does not comply with a direction within a set time, Lyfjastofnun may impose daily fines until the position is remedied, up to ISK 50,000 per day; unpaid fines accrue default interest after 30 days.

Effective from 2021-05-26

Icelandic. 'Það varðar sektum eða fangelsi allt að tveimur árum, liggi þyngri refsing ekki við broti samkvæmt öðrum lögum...' and 'Dagsektir geta numið allt að 50 þús. kr. fyrir hvern dag.' The daily-fine amount is a statutory maximum, not a tariff.

Lyfjastofnun may withdraw, recall, remove from the market or prohibit sale of a non-compliant device

recall.withdrawal-recall-and-prohibition-powers
Fact-level verified

Lyfjastofnun may by reasoned decision withdraw, recall or remove from the market a device, or prohibit its sale or supply, where it does not meet the rules and requirements for medical devices — safety, marking, instructions, certificates, declarations of conformity or test and inspection reports — and no other, milder remedy can be applied. Where an operator demonstrably obstructs an investigation or supervision, or does not give the agency sufficient information on device safety, the agency may withdraw, recall or remove the device or prohibit its sale or supply until the investigation is complete.

Effective from 2021-05-26

Icelandic. 'Lyfjastofnun getur með rökstuddri ákvörðun afturkallað, innkallað, tekið af markaði eða bannað sölu eða afhendingu tækis ef það uppfyllir ekki reglur og kröfur sem gerðar eru til lækningatækja...' Procedure on these measures follows Section 3 of Chapter VII of the Regulations.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Distributors must register with Lyfjastofnun; manufacturers, authorised representatives and importers register in the electronic system

registration.distributor-registration-duty
Fact-level verified

Manufacturers of devices other than custom-made devices, authorised representatives and importers must register in the electronic system for operator registration under Chapter III of the Regulations; Lyfjastofnun confirms the registration and issues a unique registration number (SRN). Distributors are not in that system: they must register with Lyfjastofnun itself under rules the agency sets. Distributor registration is a charged, fee-bearing act under Article 39 of the Act.

Effective from 2021-05-26

Icelandic. 'Dreifingaraðilar skulu skrá sig hjá Lyfjastofnun eftir nánari reglum sem stofnunin setur.' Article 39(5) of the same Act makes 'Skráningu dreifingaraðila, sbr. 3. mgr. 28. gr.' a head of charge. The agency's operator page confirms separately that distributors of devices must register with Lyfjastofnun.

Import is free provided the device is lawful on the European market and in Iceland

registration.import-freedom-if-lawful-in-europe
Fact-level verified

Lyfjastofnun states that importation of medical devices is conditional only on the device being lawful on the European market and in Iceland; beyond that, importation is free. There is no Icelandic import licence, import registration for the device, or pre-shipment clearance. Operators who import from within the EEA are distributors for the purposes of the Regulations and do not register in EUDAMED as importers.

Icelandic, agency guidance page (last updated 3 October 2025). 'Innflutningur á lækningatækjum er háður því skilyrði að tækið sé löglegt á Evrópumarkaði og á Íslandi. Að öðru leyti er innflutningur frjáls.' The EUDAMED distinction between EEA-established importers and distributors is set out on the agency's EUDAMED page.

Iceland keeps no register of individual medical devices

registration.no-national-device-register
Fact-level verified

There is no Icelandic register of individual medical devices and no national device-registration or device-approval filing. Lyfjastofnun states on its operator guidance that it does not keep a register of individual medical devices. Market access therefore rests entirely on conformity with the Regulations (CE marking plus EU declaration of conformity), not on an Icelandic registration number for the device.

Icelandic, agency guidance page (last updated 3 October 2025). 'Lyfjastofnun heldur ekki skrá yfir einstaka lækningatæki.' Act No. 132/2020 Art. 36 does contain a latent power for Lyfjastofnun to keep a register of devices and to limit the notification duty to certain risk classes by rules, but no such register is in operation, so the operational answer is that no device register exists.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Iceland approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Iceland (5 records)

IcelandEU conformity assessment

Prior approval / evidence record

The CE route reaches Iceland through EEA Agreement incorporation, not EU membership

reliance.eea-agreement-incorporation-mechanism
Fact-level verified
Statement

Iceland is not an EU member state. The EU route exists in Iceland because the EEA Joint Committee took MDR (EU) 2017/745, IVDR (EU) 2017/746 and Regulation (EU) 2020/561 up into the EEA Agreement (Decisions No 288/2019 and 301/2019 of 13 December 2019, and No 90 of 18 June 2020) and the Icelandic parliament then gave them the force of law by Article 2 of Act No. 132/2020, with the EEA adaptations. The practical consequence is that a CE-marked device lawfully placed on the EEA market may be placed on the Icelandic market and that the substantive obligations are the Union text as adapted, not a separate Icelandic regime.

Source Approval

EEA incorporation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (EEA Joint Committee Decisions No 288/2019, No 301/2019, No 90/2020)

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Regional Harmonisation

Local Application Required

No

Target Decision Retained

No

Effective from 2021-05-26

Icelandic. edgeType reuses the established token single_market_validity because the effect is single-market validity; the distinct mechanism recorded here is the EEA treaty incorporation itself (regulatoryLayer regional_harmonisation), which matters to a filer because the citation to give a regulator is the EEA Joint Committee decision read with the national lögfesting, and because the same route extends to all EEA states rather than only to Iceland.

IcelandEU conformity assessment

Prior approval / evidence record

Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State

Authority

Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State

Accepted

Yes

Benefit

The certificate and the CE marking it supports are valid for the Icelandic market without any Icelandic recognition step, and no Icelandic authority re-examines the conformity assessment. This is the practical reliance route into Iceland, and the reason Lyfjastofnun operates no national approval of its own.

Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devicesLög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561 have the force of law in Iceland as they are taken up in the EEA Agreement; with reglugerð nr. 907/2022 listing each instrument and its EEA Joint Committee decisionCommission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity-assessment timelines (30 days for the application review, 120 or 90 days for the assessment phase, 20 days for the final review)Lög um lækningatæki nr. 132/2020 — 28. gr. (registration of distributors with Lyfjastofnun), 36. gr. b (six-month notice before an interruption or discontinuation of supply, inserted by lög nr. 69/2025), 38. gr. (temporary prohibition of sale or supply, at most four weeks at a time), 39. gr. (the fee power)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

IcelandUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

No Icelandic route exists for non-CE approvals (FDA, PMDA, MFDS, NMPA and similar)

reliance.non-ce-approvals-no-route
Fact-level verified
Statement

An approval from a non-EEA regulator gives no market-access route and no abridgement in Iceland. Act No. 132/2020 and the Regulations provide no reference-country fast track, no abridged review based on a foreign approval, and no acceptance of a foreign registration certificate in place of CE marking. A US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be carried in the technical documentation as supporting evidence but substitutes for nothing: without CE marking and an EU declaration of conformity the device may not lawfully be placed on the Icelandic market.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

Yes

Effective from 2021-05-26

Verified negative. The Act states an exhaustive single condition for placing on the market (CE marking per Annexes IX–XI) and the Act and Regulations nowhere name a foreign regulator or a reference-country route; the agency's guidance likewise describes CE marking and the EU declaration of conformity as the route. The only non-CE access is the national exemption route in Article 9 and the Union derogations recorded under special-access-derogation, which are discretionary and are not recognition of a foreign approval.

IcelandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for the MDR conformity assessment and no shortcut to the Icelandic market, because Iceland grants no national approval to shortcut: useful as predicate documentation in the technical file and as supporting evidence in the manufacturer's own clinical evaluation.

Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devicesLög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561 have the force of law in Iceland as they are taken up in the EEA Agreement; with reglugerð nr. 907/2022 listing each instrument and its EEA Joint Committee decisionCommission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity-assessment timelines (30 days for the application review, 120 or 90 days for the assessment phase, 20 days for the final review)Lög um lækningatæki nr. 132/2020 — 28. gr. (registration of distributors with Lyfjastofnun), 36. gr. b (six-month notice before an interruption or discontinuation of supply, inserted by lög nr. 69/2025), 38. gr. (temporary prohibition of sale or supply, at most four weeks at a time), 39. gr. (the fee power)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

IcelandEU conformity assessment

Prior approval / evidence record

EU CE marking under MDR/IVDR is the Icelandic market-access route, with no separate local application

reliance.ce-marking-eea-single-market
Fact-level verified
Statement

A device that carries CE marking under MDR (EU) 2017/745 or IVDR (EU) 2017/746 and a valid EU declaration of conformity may be placed on the Icelandic market and put into service without any Icelandic pre-market approval, registration of the device, or conformity assessment. Iceland applies the same MDR/IVDR text as the EU/EEA single market, so the notified-body certificate is the market-access decision; Iceland runs no parallel review and issues no national device approval of its own.

Source Approval

EU CE under MDR/IVDR (notified-body certificate plus EU declaration of conformity per MDR Annex IV)

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

No

Effective from 2021-05-26

Icelandic. 'Áður en lækningatæki er sett á markað, selt eða tekið í notkun er skylt að CE-merkja tækið í samræmi við nánari fyrirmæli reglugerðanna og það ferli sem sett er fram í IX.–XI. viðauka með reglugerðunum.' marketAccessStrength is written as 'direct' rather than the round's 'facilitated' because no local route exists at all: there is nothing for the CE mark to shorten, and the registry already uses 'direct' with single_market_validity for the other EEA/EFTA states (Norway, Liechtenstein) and the EU member states. 'facilitated' would understate the position and imply a residual Icelandic review.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Clinical-investigation applications are assessed by Lyfjastofnun and the ethics committee under Chapter VI of the Regulations, so the MDR Article 70 periods are the national clock

clock.clinical-investigation-assessed-under-mdr-chapter-vi
Fact-level verified

A clinical investigation of a device may be carried out only with the authorisation of Lyfjastofnun and the science ethics committee. The Act directs that the application be sent to Lyfjastofnun in accordance with Chapter VI of the Regulations and that Lyfjastofnun and the ethics committee assess it in accordance with Chapter VI; the Act itself fixes no separate Icelandic decision period, so the validation and decision periods of MDR Article 70 (and IVDR Article 66 for performance studies) govern the national handling.

Conditions
  • MDR Article 70(7)(b) requires notified authorisation before class III or invasive class IIa/IIb investigations start, with no valid negative ethics opinion. The 45-day authorisation period may extend 20 days for expert consultation and pauses for requested information under Article 70(6); expiry alone does not authorise commencement.
  • The Minister may set further rules on the conduct of clinical investigations by regulation (Article 20, last paragraph); none setting a national period was found on reglugerd.is.

Effective from 2021-05-26

MDR consolidated text, 19 July 2026IVDR consolidated text, 10 January 2025

Icelandic source. Translation: 'A clinical investigation of a medical device may be carried out with the authorisation of Lyfjastofnun and the science ethics committee. Clinical investigations are governed by the detailed provisions of Chapter VI and Annexes XIV and XV of the Regulation on medical devices and Annex XIV of the Regulation on in vitro diagnostic medical devices. An application to conduct a clinical investigation shall be sent to Lyfjastofnun in accordance with Chapter VI of the Regulations. Lyfjastofnun and the science ethics committee assess the application in accordance with Chapter VI of the Regulations.' 'Reglugerðirnar' are the MDR and IVDR as incorporated into Icelandic law by Regulation No. 907/2022.

A temporary sales prohibition may last no more than four weeks, extendable by up to two weeks at a time

clocks.temporary-prohibition-four-weeks
Fact-level verified

Where there are reasoned grounds to suspect that a device does not meet the safety rules, Lyfjastofnun may temporarily prohibit its sale or supply while the investigation is under way. Such a temporary prohibition may not last longer than four weeks. It may be extended by up to two weeks at a time if special circumstances in the investigation require it. Where Lyfjastofnun considers a device particularly dangerous it may require the immediate withdrawal of all units of the device from the market.

Effective from 2021-05-26

Icelandic. 'Slíkt tímabundið bann skal ekki standa lengur en fjórar vikur. Þó er heimilt að framlengja bannið um allt að tvær vikur í senn ef sérstakar ástæður vegna rannsóknarinnar krefjast þess.' Clinical-investigation procedures separately follow the incorporated MDR/IVDR under Article 20.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Lyfjastofnun operates a national application for exemption from CE marking, with published fees by class

derogation.national-ce-marking-exemption-application
Fact-level verified

Iceland operates a national exemption route for a device without CE marking: an application for exemption from CE marking of a medical device (form 'Umsókn um undanþágu frá CE merkingu lækningatækis' on the Lyfjastofnun forms index), which the fee schedule describes as the assessment of an application to use a device that does not meet the quality and safety requirements, in the interest of public health or patient safety. The fee depends on the class: Class IIa devices and non-invasive Class IIb and III devices ISK 200,250 (item 3.3); Class IIb and III devices including implantable devices, invasive devices intended for long-term use and IVDs ISK 293,700 (item 3.4); other exemptions ISK 200,250 (item 3.5). Article 9(3) of the Act preserves Lyfjastofnun's power to withdraw a device from the market even where it is CE marked, if the device turns out to have dangerous properties.

Effective from 2025-12-17

Icelandic. The fee schedule's Chapter 3 items 3.3, 3.4 and 3.5 fix these amounts; the corresponding form 'Umsókn um undanþágu frá CE merkingu lækningatækis' is listed on the agency's forms index. The discretionary nature is confirmed by Arts. 9 and 38 of Act No. 132/2020, under which the agency may also prohibit or withdraw a device.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Harmonised standards published in the Official Journal give a presumption of conformity; the Regulation applies in Iceland through the EEA Agreement

standards.harmonised-standards-presumption-via-eea
Fact-level verified

Devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union are presumed to conform to the requirements of Regulation (EU) 2017/745 covered by those standards. The presumption also covers system or process requirements on economic operators or sponsors, including quality management, risk management, post-market surveillance, clinical investigations, clinical evaluation and post-market clinical follow-up. Act No. 132/2020 contains no Icelandic standards provision, so this Union rule is the operative one.

Conditions
  • Applies in Iceland by incorporation of the MDR and IVDR into the EEA Agreement and into Icelandic law by Act No. 132/2020 and Regulation No. 907/2022; the IVDR equivalent is Article 8 of Regulation (EU) 2017/746.
  • Harmonised standards are adopted nationally by Staðlaráð Íslands as ÍST EN standards, but no Icelandic device standards list is maintained by Lyfjastofnun.

Effective from 2021-05-26

English source. The absence of a standards provision in Act No. 132/2020 was checked by full-text search of the consolidated Act for 'staðl' (standard), which only hits the EEA Joint Committee decision titles in the preamble.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Administrative decisions under the Act may be appealed to the minister

appeal.administrative-appeal-to-the-minister
Fact-level verified

Unless the Act provides otherwise, administrative decisions taken on the basis of the Medical Devices Act may be appealed to the minister (the Minister of Health). The right of appeal and the procedure follow the Icelandic Public Administration Act (stjórnsýslulög). This is the appeal route against Lyfjastofnun decisions such as a CE-marking exemption refusal, a distributor registration decision, or a market-surveillance measure.

Effective from 2021-05-26

Icelandic. 'Sé annað ekki tekið fram í lögum þessum er heimilt að kæra stjórnvaldsákvarðanir sem teknar eru á grundvelli laga þessara til ráðherra. Um kærurétt og málsmeðferð fer samkvæmt stjórnsýslulögum.' Iceland has no separate device tribunal; the appeal is to the minister and then, if needed, to the courts.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Health institutions and health-professional offices must keep an electronic UDI register for class III implantables

udi.health-institution-implant-register
Fact-level verified

Health institutions and health-professional offices must each keep an electronic register of the UDI of Class III implantable devices they have supplied or received (Annex VIII of the MDR), and that register must record which patient received the implant, with name, kennitala and other identifiers. Economic operators must keep an electronic register of the UDI of Class III implantable devices, and of devices under Article 27(11)(a) of the MDR, that they have supplied or received; the patient-identity requirement does not apply to the operators' register. Lyfjastofnun may demand access to the institution and office registers, including patient identifiers.

Effective from 2021-05-26

Icelandic. 'Heilbrigðisstofnanir skulu halda rafræna skrá yfir einkvæma tækjaauðkenningu þeirra lækningatækja sem þær hafa afhent eða fengið afhent og tilheyra ígræðanlegum tækjum í III. flokki.' This is a hospital-side duty, not a manufacturer filing duty, and is the same structure Norway and Liechtenstein carry.

UDI system per MDR Annex VI Part C, with the manufacturer assigning and registering UDI data

udi.unique-device-identification-system
Fact-level verified

The unique device identification system is described in Part C of Annex VI of the Regulations and identifies and facilitates the traceability of devices other than custom-made and investigational devices; the details follow Chapter III of the Regulations. Before placing a device on the market, the manufacturer must assign a UDI to the device and, where applicable, to all outer packaging, must ensure that the Annex VI Part B information is correctly submitted and entered into the UDI database referred to in Article 28 of the MDR, and must keep an up-to-date list of all UDIs it has assigned.

Effective from 2021-05-26

Icelandic. Article 29 of the Act adds that distributors and importers must cooperate with manufacturers or authorised representatives to achieve the appropriate level of traceability, and must be able to identify to Lyfjastofnun all operators to whom they have supplied devices and from whom they have received them, plus all health institutions or health-professional offices concerned.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Serious-incident reporting deadlines: immediately or within 2, 10 or 15 days depending on severity

vigilance.manufacturer-reporting-deadlines-2-10-15-days
Fact-level verified

Where a manufacturer learns that a device of its manufacture may have caused, or has caused, an incident, it must determine the severity and send an initial report to Lyfjastofnun within the following time limits: serious public-health threat — without delay, or within 2 days where special reasons apply; death or serious deterioration in health — without delay, or within 10 days where special reasons apply; otherwise — without delay, or within 15 days where special reasons apply. The manufacturer must be able to justify any delay in reporting.

Icelandic, agency guidance page (last updated 3 October 2025). These are the MDR Article 87 deadlines as stated by the agency. The same page states the agency cooperates with the other competent authorities for medical devices in the EEA on market surveillance and sends and receives notifications of incidents and defects.

Anyone who makes, sells, owns or uses devices must report deviations without delay; operators must take corrective action

vigilance.national-reporting-duty-and-corrective-action
Fact-level verified

Under Icelandic law anyone who produces, sells, owns or uses medical devices and knows of a deviation, defect or malfunction that might cause or has caused harm to health must report it to Lyfjastofnun without delay. Where an operator has reason to believe that a device in its possession, intended for placing on the market or already on the market, is not safe or is otherwise not in conformity with the Regulations or the Act, it must immediately take the necessary corrective action to bring the device into conformity and withdraw or recall it as appropriate, and must inform the competent authorities.

Effective from 2021-05-26

Icelandic. This is a broader national reporting population than the MDR's manufacturer/operator circle: it reaches users and owners as well. Serious-incident corrective actions and safety corrective actions must be sent through the electronic system for vigilance referred to in Chapter VII of the Regulations, and Lyfjastofnun keeps a register of serious-incident notifications.

Manufacturer must give at least six months' notice of a foreseeable supply interruption or discontinuation

vigilance.supply-interruption-six-months-notice
Fact-level verified

Where a manufacturer of a device other than a custom-made device foresees an interruption or discontinuation of supply, and it is realistically foreseeable that the interruption or discontinuation could lead to serious harm or the risk of serious harm to patients or public health in one or more EEA States, the manufacturer must inform Lyfjastofnun as well as the operators, health institutions and health professionals to which it directly supplies the device. The information must be provided at least six months before the foreseeable interruption or discontinuation, except in exceptional circumstances, and must state the reasons.

Effective from 2026-05-12

36. gr. b was inserted by lög nr. 39/2026, 2. gr., in force 12 May 2026. The separate crisis-time information duty in 36. gr. a was inserted by lög nr. 69/2025, 8. gr. The consolidated Alþingi text was re-read in this release review.

Related structured datasets

Classification systems · 2 records
Open European Union IVD risk classification →
Id

iceland:ivd

Jurisdiction Id

iceland

Domains
  • ivd
Name

European Union IVD risk classification

Description

National projection of the directly applicable EU IVDR classification. Regulation (EU) 2017/746 is in force in Iceland from 26 May 2022 and is made law by lög um lækningatæki nr. 132/2020, with the instruments and their EEA Joint Committee decisions listed in reglugerð nr. 907/2022. IVDs are divided into classes A, B, C and D, where A is the lowest and D the highest risk, and Class A that is not sterile and has no measuring function carries no notified-body involvement. The canonical class axis and rules are maintained in eu:ivd; this scheme carries only the Icelandic references.

Classes
  • Id

    a

    Label

    IVD Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    IVD Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    IVD Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    IVD Class D

    Normalized Risk Level

    highest

Regulator

Lyfjastofnun

Official Domains
  • lyfjastofnun.is
  • althingi.is
  • reglugerd.is
  • eur-lex.europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Lög um lækningatæki nr. 132/2020 — the Icelandic act that makes Regulation (EU) 2017/746 law in Iceland and defines the IVD operator duties

    Url

    https://www.althingi.is/lagas/nuna/2020132.html

    Reviewed On

    2026-09-16

    Supports

    The act applies to in vitro diagnostic medical devices as the Regulations define them and carries the same operator, vigilance, clinical-performance and fee provisions for IVDs as for other devices; the fee schedule's device chapter prices IVD items in the same tariff. Like the MDR, the IVDR reaches Iceland through the EEA Agreement, so the class ladder is the Union one with no Icelandic delta.

  • Title

    Reglugerð nr. 907/2022 um gildistöku reglugerða Evrópusambandsins um lækningatæki — the Union instruments on medical devices, IVDs included, taken into Icelandic law with their EEA Joint Committee decisions

    Url

    https://www.reglugerd.is/reglugerdir/allar/nr/907-2022

    Reviewed On

    2026-09-16

    Supports

    Names the IVDR and the implementing and delegated acts made under it that Iceland has adopted, which is the instrument list an Icelandic IVD manufacturer follows. In force 6 August 2022, last amended by reglugerð nr. 1268/2025.

  • Title

    Lyfjastofnun, 'Um lækningatæki' — device and IVD supervision guidance, including the confirmation that no register of individual devices is kept

    Url

    https://www.lyfjastofnun.is/laekningataeki/um-laekningataeki/

    Reviewed On

    2026-09-16

    Supports

    The agency describes IVDs as within its device supervision and keeps no device-level register for them either, so the IVD scheme is likewise a projection of the Union class axis rather than an Icelandic register entry.

Inherited From Scheme Id

eu:ivd

Source Title

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Art. 47 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng

Verified On

2026-09-16

Source Supports
  • ivd-class-axis
  • ivd-classification-rules
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

iceland:medical-device

Jurisdiction Id

iceland

Domains
  • medical-device
Name

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Description

National projection of the directly applicable EU MDR classification. Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561, 'as they are taken up in the Agreement on the European Economic Area', have the force of law in Iceland under 2. gr. laga um lækningatæki nr. 132/2020, and reglugerð nr. 907/2022 lists the instruments and the EEA Joint Committee decision that took each into the Agreement. Iceland is an EEA/EFTA State and not an EU member State, so the classification rules reach the Icelandic market through Iceland's own act of incorporation rather than by direct applicability. The canonical class axis and rules are maintained in eu:medical-device; this scheme carries no national delta to them, and only the national references below describe administration or local duties.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

Lyfjastofnun

Official Domains
  • lyfjastofnun.is
  • althingi.is
  • reglugerd.is
  • eur-lex.europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Lög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745 and its implementing acts have the force of law in Iceland as they are taken up in the EEA Agreement, and the class is the one determined under the Regulations

    Url

    https://www.althingi.is/lagas/nuna/2020132.html

    Reviewed On

    2026-09-16

    Supports

    The Icelandic act of incorporation, not a national classification rule: Iceland performs no national classification review, so the Annex VIII ladder and the Article 51 classes are the operative law in Iceland unchanged. Act 132/2020 entered into force on 26 May 2021, the day the MDR became applicable, and 5. gr. sends a manufacturer/notified-body disagreement over classification to the appeals committee for medical devices rather than to a national classifying body.

  • Title

    Reglugerð nr. 907/2022 um gildistöku reglugerða Evrópusambandsins um lækningatæki — the instrument-by-instrument list of Union acts on medical devices with the EEA Joint Committee decision that took each into the Agreement

    Url

    https://www.reglugerd.is/reglugerdir/allar/nr/907-2022

    Reviewed On

    2026-09-16

    Supports

    Shows the mechanism by which the EEA States, Iceland among them, give the MDR and IVDR and their implementing acts effect: each Union instrument is named together with the EEA Joint Committee decision adopting it, so the Icelandic reader can see that the class axis arrives from the Agreement and not from a national rule. In force 6 August 2022.

  • Title

    Lyfjastofnun, 'Um lækningatæki' — the agency's own statement that it keeps no register of individual medical devices and its account of marking, classification and incident duties

    Url

    https://www.lyfjastofnun.is/laekningataeki/um-laekningataeki/

    Reviewed On

    2026-09-16

    Supports

    The negative that fixes registryMode: Lyfjastofnun sets out the device duties an operator has — CE marking, the EU declaration of conformity, classification by the manufacturer, vigilance — and separately states that it does not keep a register of individual medical devices. There is therefore no Icelandic class register to model, and the scheme publishes as a projection rather than as an administered national ladder.

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Iceland registration →
Country

Iceland

Jurisdiction Id

iceland

Country Code

IS

Flag

🇮🇸

Regulator

Lyfjastofnun (Icelandic Medicines Agency)

Regulator Abbrev

Lyfjastofnun

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR as incorporated into the EEA Agreement

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devices

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    9

    Notes
    • MDR Art. 52(7): a Class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared by the manufacturer, so no authority and no notified body reviews the file and there is no review clock to publish. The regulation has the force of law in Iceland under 2. gr. laga um lækningatæki nr. 132/2020, which is why an MDR article fixes the Icelandic row.
    • Elapsed time to the Icelandic market is the manufacturer's own technical documentation plus EUDAMED actor and device registration, with the Icelandic-language duty for general-public instructions under reglugerð nr. 630/2022 running alongside. None of those steps has a guaranteed processing time in any Icelandic instrument — see unresolved.timeline-national-clock.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for the MDR conformity assessment and no shortcut to the Icelandic market, because Iceland grants no national approval to shortcut: useful as predicate documentation in the technical file and as supporting evidence in the manufacturer's own clinical evaluation.

  • Authority

    Notified body certificate under Regulation (EU) 2017/745 issued in any EEA State

    Accepted

    Yes

    Benefit

    The certificate and the CE marking it supports are valid for the Icelandic market without any Icelandic recognition step, and no Icelandic authority re-examines the conformity assessment. This is the practical reliance route into Iceland, and the reason Lyfjastofnun operates no national approval of its own.

Key Requirements
  • 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.
Local Rep Required

Yes

Local Rep Name

EEA authorised representative (viðurkenndur fulltrúi)

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (MDR notified-body certificate validity); no Icelandic registration exists to renew and no national renewal fee is charged

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    Regulation (EU) 2017/745 on medical devices, Art. 51 and Art. 52(7) — the classes and the self-declaration route for Class I devices

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

  • Title

    Lög um lækningatæki nr. 132/2020, 2. gr. — Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561 have the force of law in Iceland as they are taken up in the EEA Agreement; with reglugerð nr. 907/2022 listing each instrument and its EEA Joint Committee decision

    Url

    https://www.althingi.is/lagas/nuna/2020132.html

    Effective Date

    2021-05-26

    Accessed Date

    2026-09-16

  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity-assessment timelines (30 days for the application review, 120 or 90 days for the assessment phase, 20 days for the final review)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-09-16

  • Title

    Lög um lækningatæki nr. 132/2020 — 28. gr. (registration of distributors with Lyfjastofnun), 36. gr. b (six-month notice before an interruption or discontinuation of supply, inserted by lög nr. 69/2025), 38. gr. (temporary prohibition of sale or supply, at most four weeks at a time), 39. gr. (the fee power)

    Url

    https://www.althingi.is/lagas/nuna/2020132.html

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Lyfjastofnun. Appoint a EEA authorised representative (viðurkenndur fulltrúi).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Lyfjastofnun including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Lyfjastofnun reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Lyfjastofnun may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Lyfjastofnun issues Iceland market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Iceland fees →
Jurisdiction Id

iceland

Country

Iceland

Country Code

IS

Authority

Lyfjastofnun

Low Risk Local
Min

200250

Max

200250

Currency

ISK

Per Product

No

High Risk Local
Min

293700

Max

293700

Currency

ISK

Per Product

No

Details
  • Id

    free-sales-certificate

    Item

    Free Sales Certificate (FSC) for a medical device — five copies

    Currency

    ISK

    Amount Local

    53400

    Amount Local Formatted

    ISK 53,400

    Frequency

    Per certificate

    Notes

    Tariff item 1.1. Issued under 6. mgr. 6. gr. laga um lækningatæki nr. 132/2020. If issuing the certificate needs substantial preparation, the hourly rate in item 7.1 may be charged on top.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    free-sales-certificate-additional-copy

    Item

    Free Sales Certificate for a medical device or an IVD — price per copy beyond the first five

    Currency

    ISK

    Amount Local

    26700

    Amount Local Formatted

    ISK 26,700

    Frequency

    Per additional copy

    Notes

    Tariff item 1.2.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    other-certificates

    Item

    Other certificates — price per copy

    Currency

    ISK

    Amount Local

    40050

    Amount Local Formatted

    ISK 40,050

    Frequency

    Per copy

    Notes

    Tariff item 1.3. The hourly rate under item 7.1 may be added where issuing the certificate requires substantial preparation.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    distributor-registration

    Item

    Registration of a distributor in Lyfjastofnun's distributor register

    Currency

    ISK

    Amount Local

    53400

    Amount Local Formatted

    ISK 53,400

    Frequency

    Per registration

    Notes

    Tariff item 2.1, charged under 3. mgr. 28. gr. laga um lækningatæki nr. 132/2020. 'Dreifingaraðili' covers every person or legal entity in the supply chain other than the manufacturer or importer who offers a device on the market until it is put into use. This is the only Icelandic entry that registers an operator rather than a device.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    distributor-registration-maintenance

    Item

    Maintenance of a distributor registration

    Currency

    ISK

    Amount Local

    26700

    Amount Local Formatted

    ISK 26,700

    Frequency

    Per maintenance registration

    Notes

    Tariff item 2.2. The separate maintenance charge shows the distributor registration is kept current rather than being a one-off filing.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    use-supervision-device

    Item

    Supervision of use — supervision of a medical device or an in vitro diagnostic medical device

    Currency

    ISK

    Amount Local

    160200

    Amount Local Formatted

    ISK 160,200

    Frequency

    Per supervision case

    Notes

    Tariff item 3.1, charged under 1. mgr. 16. gr. laga nr. 132/2020; supervision of use means checking that use matches the intended purpose and that users have minimum training. Where the supervision proves extensive the hourly rate in item 7.1 may be added, and the invoice issues once the supervision report exists.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    use-supervision-management-system

    Item

    Supervision of use — supervision of a management system

    Currency

    ISK

    Amount Local

    387150

    Amount Local Formatted

    ISK 387,150

    Frequency

    Per supervision case

    Notes

    Tariff item 3.2.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    ce-exemption-assessment-class-iia-and-non-invasive-iib-iii

    Item

    Assessment of an application for exemption from the CE-marking requirements — Class IIa devices and devices that are not invasive in Class IIb and III

    Currency

    ISK

    Amount Local

    200250

    Amount Local Formatted

    ISK 200,250

    Frequency

    Per application

    Notes

    Tariff item 3.3, charged under 4. mgr. 3. gr. This is the lower-risk end of the only class-differentiated pair of amounts in the schedule. The Icelandic text reads 'lækningatæki í flokki IIa, og tæki sem ekki eru inngripstæki í flokki IIb og III'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    ce-exemption-assessment-class-iib-iii

    Item

    Assessment of an application for exemption from the requirements — Class IIb and III devices, including implantable devices, invasive devices intended for long-term use and in vitro diagnostic medical devices

    Currency

    ISK

    Amount Local

    293700

    Amount Local Formatted

    ISK 293,700

    Frequency

    Per application

    Notes

    Tariff item 3.4. This is the higher-risk end of the only class-differentiated pair of amounts in the schedule, and the reason the high-risk band is set at this figure.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    other-exemptions

    Item

    Other exemptions

    Currency

    ISK

    Amount Local

    200250

    Amount Local Formatted

    ISK 200,250

    Frequency

    Per application

    Notes

    Tariff item 3.5.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    maintenance-supervision-device

    Item

    Supervision of maintenance — supervision of a medical device

    Currency

    ISK

    Amount Local

    200250

    Amount Local Formatted

    ISK 200,250

    Frequency

    Per supervision case

    Notes

    Tariff item 4.1, charged under 1. mgr. 17. gr. laga nr. 132/2020; supervision of maintenance covers periodic quality and safety inspection and servicing against the manufacturer's specification.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    maintenance-supervision-management-system

    Item

    Supervision of maintenance — supervision of a management system

    Currency

    ISK

    Amount Local

    387150

    Amount Local Formatted

    ISK 387,150

    Frequency

    Per supervision case

    Notes

    Tariff item 4.2.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    market-surveillance-distributors-importers

    Item

    Market surveillance — distributors and importers

    Currency

    ISK

    Amount Local

    133500

    Amount Local Formatted

    ISK 133,500

    Frequency

    Per supervision case

    Notes

    Tariff item 5.1, charged under 1. mgr. 34. gr. laga nr. 132/2020. Lyfjastofnun takes up device-safety cases and operator-duty cases on its own initiative or on a report.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    quality-management-distributors-importers

    Item

    Quality management — distributors and importers

    Currency

    ISK

    Amount Local

    387150

    Amount Local Formatted

    ISK 387,150

    Frequency

    Per supervision case

    Notes

    Tariff item 5.2.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    market-surveillance-manufacturers-authorised-representatives

    Item

    Market surveillance — manufacturers and authorised representatives

    Currency

    ISK

    Amount Local

    133500

    Amount Local Formatted

    ISK 133,500

    Frequency

    Per supervision case

    Notes

    Tariff item 5.3. The Icelandic text names the authorised representative as 'viðurkenndur fulltrúi', the EEA-established representative Act 132/2020 requires of a manufacturer outside the EEA.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    quality-management-manufacturers-authorised-representatives

    Item

    Quality management — manufacturers and authorised representatives

    Currency

    ISK

    Amount Local

    774300

    Amount Local Formatted

    ISK 774,300

    Frequency

    Per supervision case

    Notes

    Tariff item 5.4. The highest item in the schedule.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-pre-check-lower-classes

    Item

    Pre-check of the content of an application for a clinical or performance investigation — Class I devices, non-invasive Class IIa and IIb devices, and IVD Class A

    Currency

    ISK

    Amount Local

    200250

    Amount Local Formatted

    ISK 200,250

    Frequency

    Per application

    Notes

    Tariff item 6.1, charged under 2. mgr. 6. gr. laga nr. 132/2020.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-pre-check-higher-classes

    Item

    Pre-check of the content of an application for a clinical or performance investigation — Class IIa, IIb and III devices and IVD Classes B, C and D

    Currency

    ISK

    Amount Local

    200250

    Amount Local Formatted

    ISK 200,250

    Frequency

    Per application

    Notes

    Tariff item 6.2. The amount equals item 6.1: this part of the tariff turns on the check performed, not on the class.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-assessment

    Item

    Assessment of an application for a clinical investigation of a medical device — all classes of device

    Currency

    ISK

    Amount Local

    1161450

    Amount Local Formatted

    ISK 1,161,450

    Frequency

    Per application

    Notes

    Tariff item 6.3. The item applies to every device class, so it is not a class-differentiated amount and is not used to build either risk band. Fees under 6. gr. are irrevocable even if the application is refused or withdrawn; where the fee does not cover the cost of assessment the applicant pays the hourly rate for the shortfall and may withdraw within 14 days of being told.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-approved-inspection

    Item

    Clinical investigation of medical devices approved by Lyfjastofnun

    Currency

    ISK

    Amount Local

    387150

    Amount Local Formatted

    ISK 387,150

    Frequency

    Per approval

    Notes

    Tariff item 6.4.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-amendments

    Item

    Amendments to a clinical investigation of medical devices

    Currency

    ISK

    Amount Local

    106800

    Amount Local Formatted

    ISK 106,800

    Frequency

    Per amendment

    Notes

    Tariff item 6.5.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

  • Id

    hourly-rate-specialist

    Item

    Lyfjastofnun hourly rate — per specialist, per hour, for supervision and services under the Medical Devices Act

    Currency

    ISK

    Amount Local

    26700

    Amount Local Formatted

    ISK 26,700

    Frequency

    Per specialist-hour

    Notes

    Tariff item 7.1. Charged in addition to the fixed items where supervision proves extensive, where a certificate needs substantial preparation, for site inspections during a clinical investigation, and for follow-up and enforcement action under Chapter VII of Act 132/2020.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Source Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Source Effective Date

    2026-01-01

    Verified On

    2026-09-16

Notes
  • Gjaldskrá nr. 1529/2025 is the fee schedule in force: it was made by the Ministry of Health on 17 December 2025 under the authority of 39. gr. laga um lækningatæki nr. 132/2020, took effect on 1 January 2026, and at that moment repealed gjaldskrá nr. 1555/2023.
  • Iceland charges no device-registration fee and no device-approval fee, because it operates no national device registration and no national device approval. Every amount in this record is a certificate, operator-registration, supervision, clinical-investigation or hourly charge that an applicant or an operator can actually be billed for.
  • The two risk bands are the reporter's grouping of published line items, not a published range. The schedule is a supervision and service tariff and all but one pair of its amounts are flat: the only amounts that turn on the device class are items 3.3 (ISK 200,250, Class IIa and non-invasive Class IIb/III exemption assessment) and 3.4 (ISK 293,700, Class IIb/III, including implantables, long-term invasive devices and IVDs). Both bands are therefore single published amounts rather than spreads, and the per-device cost of the tariff does not track the class axis.
  • The most consequential charges are annual and risk-based rather than transactional: market surveillance of a manufacturer or authorised representative is ISK 133,500, and quality-management supervision of the same operator is ISK 774,300, so an Icelandic market presence is priced mainly through supervision rather than through a market-entry fee.
  • Fees are exclusive of the travel and accommodation costs Lyfjastofnun charges separately under 8. gr. for on-site supervision, and are subject to the payment terms in 10. gr. — 30 days from invoice, with default interest and enforceability.
  • Amounts are as published in the B-deild of Stjórnartíðinda; the Icelandic convention writes them with a full stop as the thousands separator, and they are rendered here with a comma.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Gjaldskrá nr. 1529, 17. desember 2025 — gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule No. 1529/2025 for the supervision of medical devices by Lyfjastofnun), set under 39. gr. laga um lækningatæki nr. 132/2020; B-deild Stjórnartíðinda, published 30 December 2025

    Url

    https://www.lyfjastofnun.is/wp-content/uploads/2026/01/b-nr-1529-2025.pdf

    Effective Date

    2026-01-01

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Iceland certifications →
Slug

iceland

Market

Iceland

Confidence

high

Schemes
  • Id

    lvd-medical-equipment-outside-scope

    Name

    Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Electrical Medical Equipment

    Note

    Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, and MDR Annex I section 18.7 fixes the electrical-safety requirements for a medical device, so no separate Icelandic electrical-safety certificate exists for a device. Iceland is an EEA State rather than an EU member State: the directive binds Iceland through the EEA Agreement and is carried into Icelandic law by Iceland's own transposing regulation, which this round did not retrieve, so this row is bound to the Union directive as a candidate. Where the equipment is also radio equipment, reglugerð nr. 944/2019 Article 7 applies the same health-and-safety requirement with no voltage limitation and Fjarskiptastofa enforces it. The applicant's evidence is the MDR technical file with the IEC/EN 60601 series carrying the presumption of conformity.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    • https://eur-lex.europa.eu/eli/reg/2017/745/oj
    Source Binding

    candidate

  • Id

    emc-iceland-regulation-303-2018

    Name

    Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Electrical Medical Equipment

    Note

    Reglugerð nr. 303/2018 um rafsegulsamhæfi transposes Directive 2014/30/EU into Icelandic law — 26. gr. names the directive and EEA Joint Committee Decision No 46/2016 — and 13. gr. makes CE marking a condition of placing equipment on the market in Iceland, with the manufacturer obliged to affix a visible, legible and indelible mark. Article 1, fourth paragraph, switches the regulation off for equipment where another specific instrument lays the same essential requirements down more precisely, which is what MDR Annex I sections 18.5 and 18.6 do for a medical device, so for a device the EMC evidence sits in the MDR technical file and no separate Icelandic EMC certificate is issued. 18. gr. gives market surveillance to Mannvirkjastofnun, whose functions now sit in the Húsnæðis-, mannvirkja- og skipulagsstofnun (HMS); for equipment that is not a medical device the regulation applies directly. The regulation took effect on 24 March 2018 and repealed reglugerðir nr. 397/2012 and nr. 786/2014.

    Source Urls
    • https://www.reglugerd.is/reglugerdir/allar/nr/303-2018
    • https://eur-lex.europa.eu/eli/reg/2017/745/oj
    Source Binding

    reviewed

  • Id

    fjarskiptastofa-radio-equipment-944-2019

    Name

    Fjarskiptastofa radio-equipment market access (reglugerð nr. 944/2019)

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Reglugerð nr. 944/2019 um þráðlausan fjarskiptabúnað implements Directive 2014/53/EU, taken into the EEA Agreement by Joint Committee Decision No 89/2016, together with Commission Delegated Regulations (EU) 2022/2380, 2023/1717 and 2023/2444 adopted by Decisions No 238/2023, 24/2025 and 25/2025, and applies to radio equipment on Icelandic territory. Article 7 permits radio equipment to be placed on the market and taken into use only if it complies with the regulation, bears CE marking, is correctly installed and is used for its intended purpose; Article 10 requires the documentation and information for Icelandic users to be in Icelandic, or in English or a Nordic language other than Finnish where the user group can be expected to understand it. Article 11(1) makes Fjarskiptastofa the market-surveillance authority for radio equipment and its operators, with Neytendastofa assisting, the accreditation division of Hugverkastofa assessing notified bodies, and the police and customs supporting the authority. There is no Icelandic type approval: the applicant relies on the RED conformity route and the EU declaration of conformity, and notification to the EFTA Surveillance Authority and the Commission follows Article 13.

    Source Urls
    • https://www.reglugerd.is/reglugerdir/allar/nr/944-2019
    Source Binding

    reviewed

  • Id

    hms-legal-metrology-91-2006

    Name

    HMS legal-metrology conformity assessment and verification (lög nr. 91/2006)

    Category

    Legal Metrology

    Status

    Mandatory For Use Site

    Object

    Legal Measuring Instruments

    Note

    Lög nr. 91/2006 um mælingar, mæligrunna og vigtarmenn governs legal metrology in Iceland: 4. gr. 1. mgr. gives the minister overall charge and puts implementation in the hands of the Húsnæðis-, mannvirkja- og skipulagsstofnun (HMS), and 4. gr. 2. mgr. d-lið gives that body market surveillance and the contacts with other EEA surveillance authorities. Article 10 requires conformity assessment to be completed and demonstrably recorded before a measuring instrument is first offered for sale or put into use, and Article 14 requires an instrument in use to be confirmed as compliant by löggilding. Article 17 gives HMS supervision, which it may contract to independent, competent bodies, and Article 31 sets a löggildingargjald of 15-25% of the service fee charged to the instrument's owner when verification is carried out. A sphygmomanometer or a weighing instrument used in medical practice therefore needs its own Icelandic verification; the CE mark on a medical device does not discharge that duty.

    Source Urls
    • https://www.althingi.is/lagas/nuna/2006091.html
    Source Binding

    reviewed

  • Id

    geislavarnir-ionizing-radiation-44-2002

    Name

    Geislavarnir ríkisins licence for ionizing-radiation sources and radiation devices

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Ionizing Radiation Sources And Radiation Devices

    Note

    Lög nr. 44/2002 um geislavarnir Article 7 makes the production, import, export, possession, storage, delivery, use, recycling, recovery and disposal of radioactive substances subject to a licence from Geislavarnir ríkisins, and its later paragraph adds that the use of notification-triggered radiation devices emitting ionizing radiation is likewise 'háð leyfi Geislavarna ríkisins' — import of such a device is only notifiable. An X-ray, CT or accelerator-based medical device therefore needs an Icelandic licence for its use in Iceland even though it contains no radioactive source, and the licence is a use-site obligation that sits outside the MDR conformity route. Article 19 requires the licence holder to pay for regular inspection and licence assessment on a tariff the minister sets on the institution's proposal, and Article 21 covers the tariff for the institution's service measurements.

    Source Urls
    • https://www.althingi.is/lagas/nuna/2002044.html
    Source Binding

    reviewed

  • Id

    urvinnslusjodur-weee-levy-442-2015

    Name

    Producer responsibility and the úrvinnslugjald as a condition of placing electrical and electronic equipment on the Icelandic market

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Electrical And Electronic Equipment

    Note

    Reglugerð nr. 442/2015 um raf- og rafeindatækjaúrgang, 6. gr. 2. mgr., states that it is prohibited to place on the market, sell in Iceland or take into commercial use electrical and electronic equipment covered by the regulation unless the manufacturer and the importer pay the úrvinnslugjald (recycling levy) provided for in lög nr. 162/2002 on the recycling levy, so this is a money condition on market placement and not a certificate. The levy is collected through the tax authority and the producer-responsibility scheme is administered by Úrvinnslusjóður, which arranges collection and treatment of the waste stream, with Umhverfisstofnun receiving the annual data producers and importers must report. The regulation took effect on publication on 12 May 2015 and superseded reglugerð nr. 1104/2008. Batteries are handled under their own instrument, reglugerð nr. 1020/2011 um rafhlöður og rafgeyma, which was not retrieved in full, so no battery-specific row is published.

    Source Urls
    • https://island.is/stjornartidindi/nr/143c42da-5538-4377-8789-442cb4e10c06
    Source Binding

    reviewed

Official Sources
  • Authority

    Lyfjastofnun

    Topic

    operator duties, distributor registration and medical-device supervision in Iceland

    Url

    https://www.lyfjastofnun.is/laekningataeki/rekstur-og-dreifing-laekningataekja/

  • Authority

    Lyfjastofnun

    Topic

    national competent authority for Regulation (EU) 2017/745 and Regulation (EU) 2017/746 in Iceland; no register of individual medical devices

    Url

    https://www.lyfjastofnun.is/laekningataeki/um-laekningataeki/

  • Authority

    Húsnæðis-, mannvirkja- og skipulagsstofnun (HMS), formerly Mannvirkjastofnun

    Topic

    Reglugerð nr. 303/2018 um rafsegulsamhæfi — Icelandic transposition of Directive 2014/30/EU

    Url

    https://www.reglugerd.is/reglugerdir/allar/nr/303-2018

  • Authority

    Fjarskiptastofa

    Topic

    Reglugerð nr. 944/2019 um þráðlausan fjarskiptabúnað — Icelandic implementation of Directive 2014/53/EU

    Url

    https://www.reglugerd.is/reglugerdir/allar/nr/944-2019

  • Authority

    Húsnæðis-, mannvirkja- og skipulagsstofnun (HMS)

    Topic

    Lög nr. 91/2006 um mælingar, mæligrunna og vigtarmenn — Icelandic legal metrology

    Url

    https://www.althingi.is/lagas/nuna/2006091.html

  • Authority

    Geislavarnir ríkisins

    Topic

    Lög nr. 44/2002 um geislavarnir — Icelandic radiation protection licensing

    Url

    https://www.althingi.is/lagas/nuna/2002044.html

  • Authority

    Umhverfisstofnun / Úrvinnslusjóður

    Topic

    Reglugerð nr. 442/2015 um raf- og rafeindatækjaúrgang — WEEE producer responsibility and the úrvinnslugjald

    Url

    https://island.is/stjornartidindi/nr/143c42da-5538-4377-8789-442cb4e10c06

  • Authority

    EUR-Lex

    Topic

    Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    Regulation (EU) 2017/745 on medical devices

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

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