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February 8, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Icelandic Act on Medical Devices No. 132/2020
1. Purpose and Scope
The Act ensures the quality and safety of medical devices, prioritizing public safety and aligning with best professional knowledge. It transposes EU Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), with adaptations from EEA decisions. The scope includes production, importing, distribution, sale, placing on the market, market surveillance, maintenance, and use of medical devices. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
2. Definitions
Key terms: medical device (instrument for diagnosis, treatment, etc.); in vitro diagnostic (for specimen examination); manufacturer (entity marketing under own name); importer (placing non-EEA devices on market); distributor (in supply chain); authorised representative (for non-EEA manufacturers); CE marking (conformity mark); recall/withdrawal (safety measures); UDI (device identifier); clinical investigation (safety/performance study). https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
3. Obligations of Economic Operators
Manufacturers: Ensure compliance, conduct evaluations, maintain documentation, establish systems for quality, risk, and surveillance, appoint compliance person. Importers/Distributors: Verify conformity, labeling, etc. Authorised representatives: Act for non-EEA manufacturers. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
4. Conformity Assessment and CE Marking
Demonstrate conformity via assessment; affix CE marking per Regulations. Notified bodies conduct assessments. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
5. Registration
Operators register in EUDAMED; healthcare institutions register UDIs for certain devices. Iceland participates in EUDAMED. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
6. Clinical Investigations
Require IMA and Bioethics Committee license; follow Regulations. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
7. Vigilance and Post-Market Surveillance
Manufacturers implement surveillance; report incidents. IMA maintains registers. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
8. Market Surveillance
IMA supervises, inspects, enforces corrective actions. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
9. Language Requirements
Information in Icelandic for public-use devices. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
10. Penalties
Fines for violations; criminal penalties for serious offenses. https://www.government.is/library/04-Legislation/Act_on_Medical_Devices%20No132_2020.pdf
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Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
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