Lyfjastofnun · Europe

Iceland medical device regulatory resources

Every Iceland dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with records4 regulations trackedSep 2026 fees reviewed

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AI medical device classifier

Describe your device and get a preliminary Lyfjastofnun risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Iceland requirements.

Government registration fees

Review current Lyfjastofnun application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

Browse Iceland's official medical-device instruments — the 2020 Medical Devices Act, its implementing regulations, and Lyfjastofnun's fee schedule — with citeable Icelandic passages.

Structured regulatory requirements

Explore all 45 source-linked facts →

23 of 25 research dimensions currently covered · 20 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

Lyfjastofnun is the competent authority for MDR and IVDR in Iceland: 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). It…
Lyfjastofnun carries market surveillance and may prioritise cases: 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…

3 source-linked facts

Checked 2026-09-16

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D02

Legal basis & guidance

Verified

Act No. 132/2020 entered into force on 26 May 2021, the MDR application date: The Icelandic Medical Devices Act (lög um lækningatæki nr. 132/2020) entered into force on 26 May 2021, the same day the MDR became applicable, and it is the national act that carries Icela…
MDR, IVDR and Regulation (EU) 2020/561 have the force of law in Iceland through EEA Joint Committee Decisions and Act No. 132/2020: Iceland is an EEA/EFTA state, not an EU member state. Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561, 'as they are taken up in the Agreement on the European…

3 source-linked facts

Checked 2026-09-16

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D03

Device definition & scope

Verified

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

1 source-linked fact

Checked 2026-09-16

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D04

Classification rules

Verified

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

1 maintained scheme · 1 related fact

Checked 2026-09-16

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D05

Registration pathways

Verified

Distributors must register with Lyfjastofnun; manufacturers, authorised representatives and importers register in the electronic system: 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 R…
Import is free provided the device is lawful on the European market and in Iceland: 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 I…

3 source-linked facts

Checked 2026-09-16

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D06

Reliance & recognition

Verified

EU CE marking under MDR/IVDR is the Icelandic market-access route, with no separate local application: 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…
The CE route reaches Iceland through EEA Agreement incorporation, not EU membership: 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…

3 source-linked facts

Checked 2026-09-16

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D07

Economic-operator roles

Verified

An authorised representative established anywhere in the EEA is sufficient for Iceland: 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…
Manufacturer, authorised representative, importer and distributor are distinct roles; a non-EEA manufacturer must appoint an authorised representative: 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 ma…

2 source-linked facts

Checked 2026-09-16

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D08

Establishment, import & distribution

Verified

Distributor must verify CE marking, manufacturer information, importer compliance and UDI: 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 i…
Importer must verify four things before offering a device on the Icelandic market: 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 i…

3 source-linked facts

Checked 2026-09-16

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D09

Dossier requirements

Verified

The dossier Iceland expects is the EU package: CE marking, EU declaration of conformity and MDR Annex I information: 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…
No Icelandic dossier is filed with the authority; technical documentation is held by the manufacturer: 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 th…

2 source-linked facts

Checked 2026-09-16

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D10

Official forms & portals

Verified

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

1 source-linked fact

Checked 2026-09-16

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Submission & evidence

D11

Label, IFU & language

Verified

Implant cards issued to patients must as a rule be in Icelandic: 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 Finni…
Instructions for use for the general public must be in Icelandic, with a class I/IIa exception: 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…

3 source-linked facts

Checked 2026-09-16

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D12

QMS, audit & inspection

Verified

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

1 source-linked fact

Checked 2026-09-16

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D13

Standards, testing & ancillary approvals

Unresolved

Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment: Electrical safety
Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device: EMC
Fjarskiptastofa radio-equipment market access (reglugerð nr. 944/2019): Wireless / radio

6 maintained overlays · 1 related fact

Checked 2026-09-16

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D14

Fees

Verified

Free Sales Certificate (FSC) for a medical device — five copies: ISK 53,400
Free Sales Certificate for a medical device or an IVD — price per copy beyond the first five: ISK 26,700

22 maintained fee lines · 1 related fact

Checked 2026-09-16

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 2 related facts

Checked 2026-09-16

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D16

Approval validity & renewal

Verified

Distributor registration is charged as registration plus maintenance registration; no interval or expiry is published: 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 dis…
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: 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 wit…

2 source-linked facts

Checked 2026-09-16

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Lifecycle & post-market

D17

Change control

Verified

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

1 source-linked fact

Checked 2026-09-16

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D18

UDI, listing & traceability

Verified

Health institutions and health-professional offices must keep an electronic UDI register for class III implantables: 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),…
UDI system per MDR Annex VI Part C, with the manufacturer assigning and registering UDI data: 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 investiga…

2 source-linked facts

Checked 2026-09-16

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D19

Clinical investigation & performance

Verified

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

1 source-linked fact

Checked 2026-09-16

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D20

Special access & derogation

Verified

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

1 source-linked fact

Checked 2026-09-16

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D21

Manufacturer PMS

Verified

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

1 source-linked fact

Checked 2026-09-16

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D22

Vigilance & incident reporting

Verified

Serious-incident reporting deadlines: immediately or within 2, 10 or 15 days depending on severity: 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 th…
Anyone who makes, sells, owns or uses devices must report deviations without delay; operators must take corrective action: 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…

3 source-linked facts

Checked 2026-09-16

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D23

Recall, FSCA & market surveillance

Verified

Breaches carry fines or up to two years' imprisonment; daily fines up to ISK 50,000 per day: 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 investigati…
Lyfjastofnun may withdraw, recall, remove from the market or prohibit sale of a non-compliant device: 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 devi…

2 source-linked facts

Checked 2026-09-16

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D24

Advertising, claims & promotion

Verified

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

1 source-linked fact

Checked 2026-09-16

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D25

Submission communications & appeal

Verified

Administrative decisions under the Act may be appealed to the minister: 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 t…

1 source-linked fact

Checked 2026-09-16

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Government fees

Full fee schedule (22 lines) →

Lyfjastofnun registration fees in ISK · reviewed 2026-09-16

Fee line	Amount	Provenance
Free Sales Certificate (FSC) for a medical device — five copies	ISK 53,400	Verified
Free Sales Certificate for a medical device or an IVD — price per copy beyond the first five	ISK 26,700	Verified
Other certificates — price per copy	ISK 40,050	Verified
Registration of a distributor in Lyfjastofnun's distributor register	ISK 53,400	Verified

18 more fee lines on the full schedule · 22 of 22 rows source-verified

Registration timeline

Full registration timeline →

Lyfjastofnun (Icelandic Medicines Agency) (Lyfjastofnun) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR as incorporated into the EEA Agreement classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Self-declaration (no notified body))	0 days	6-9 months	Verified

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(0 days)
5Registration Approval(1-2 weeks)

Key regulations

All 4 Iceland regulations →

Official Lyfjastofnun rules and guidance · 4 of 4 documents linked to official sources

Lög nr. 132/2020Lög um lækningatæki (Act on Medical Devices)

GeneralVerified

Gjaldskrá nr. 1529/2025Gjaldskrá vegna eftirlits Lyfjastofnunar með lækningatækjum (Fee schedule for the Icelandic Medicines Agency's supervision of medical devices)

RegistrationVerified

Reglugerð nr. 630/2022Reglugerð um notkunarleiðbeiningar sem fylgja lækningatækjum (Regulation on instructions for use accompanying medical devices)

LabelingVerified

Reglugerð nr. 907/2022Reglugerð um gildistöku reglugerða Evrópusambandsins um lækningatæki (Regulation on the entry into force of the European Union regulations on medical devices)

GeneralVerified

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