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