🇮🇸Europe

Medical Device Regulation in Iceland

Iceland, as a member of the European Economic Area (EEA), applies the EU Medical Device Regulation (EU MDR 2017/745) through its EEA Agreement obligations. The Icelandic Medicines Agency (Lyfjastofnun) serves as the national competent authority for medical devices. Iceland's small but well-regulated market ensures device safety standards aligned with the broader European framework.

FrameworkEU Medical Device Regulation (EU MDR 2017/745) as adopted into the EEA Agreement; Icelandic Act on Medical Devices (Lög um lækningatæki).

Classification systemClass I / Class IIa / Class IIb / Class III

Primary agencyLyfjastofnun

RegionEurope

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Device Classification

Class IClass IIaClass IIbClass III

Iceland follows the EU MDR risk-based classification system. Class I devices are low risk (e.g., bandages, tongue depressors). Class IIa devices carry medium-low risk (e.g., hearing aids, surgical clamps). Class IIb devices are medium-high risk (e.g., ventilators, infusion pumps). Class III devices are highest risk (e.g., implantable cardiac devices, hip prostheses). Classification is determined by factors including duration of contact, degree of invasiveness, and dependence on an energy source.

Official classification guidance →

Official Regulatory Bodies

Lyfjastofnun↗

Icelandic Medicines AgencyNational competent authority responsible for the regulation and market surveillance of medical devices in Iceland.

Official Guidance Documents

Icelandic Medicines Agency – Medical Devices↗

Official guidance on medical device registration and regulation in Iceland.

EU MDR 2017/745 Full Text↗

The full text of the EU Medical Device Regulation applicable in Iceland through the EEA Agreement.

Standards & Key Principles

Applicable Standards

ISO 13485 – Quality Management Systems for Medical DevicesISO 14971 – Risk Management for Medical DevicesIEC 60601 – Safety and Performance of Medical Electrical EquipmentIEC 62304 – Medical Device Software Lifecycle ProcessesISO 10993 – Biological Evaluation of Medical Devices

Key Principles

CE marking is required for all medical devices placed on the Icelandic market under the EEA Agreement.
Manufacturers must appoint an EU/EEA Authorized Representative if not established within the EEA.
Unique Device Identification (UDI) requirements follow the EU MDR timeline.
Post-market surveillance obligations align with EU MDR Chapter VII.
Notified Bodies designated under the EU MDR framework are recognized in Iceland.

Pre-Market Requirements

Conformity Assessment

Manufacturers must undergo conformity assessment procedures as defined in the EU MDR, involving Notified Bodies for Class IIa, IIb, and III devices.

CE Marking

Devices must bear the CE mark before being placed on the Icelandic market, demonstrating conformity with applicable EU MDR requirements.

Technical Documentation

Comprehensive technical documentation must be prepared and maintained, including clinical evaluation reports, risk management files, and design verification/validation records.

EUDAMED Registration

Manufacturers and devices must be registered in the European Database on Medical Devices (EUDAMED) as it becomes fully functional.

Post-Market Requirements

Post-Market Surveillance (PMS)

Manufacturers must maintain a PMS system to proactively collect and review data on device safety and performance throughout the device lifecycle.

Vigilance Reporting

Serious incidents and field safety corrective actions must be reported to Lyfjastofnun in line with EU MDR vigilance requirements.

Periodic Safety Update Reports (PSUR)

Manufacturers of Class IIa, IIb, and III devices must submit PSURs summarizing PMS data and conclusions at defined intervals.

International Recognition & Reliance

European Union

Through the EEA Agreement, Iceland mutually recognizes CE-marked devices approved under EU MDR 2017/745.