Icelandic Medicines Agency (IMA) - Medical Device Regulation

The Icelandic Medicines Agency (IMA), known locally as Lyfjastofnun, is the competent authority (CA) responsible for the regulation and surveillance of medical devices in Iceland. Its primary mission is to ensure that medical devices are safe, effective, and comply with current legislation to prevent patient harm.

1. Regulatory Framework

Iceland is a member of the European Economic Area (EEA), meaning it follows the European Union's regulatory framework for medical technology. The primary legislation includes:

• Act on Medical Devices No. 132/2020: This act incorporates the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 into Icelandic law.
• It covers the production, import, distribution, and clinical investigation of medical devices.

2. Key Roles and Responsibilities

The IMA performs several critical functions to maintain market safety:

Market Surveillance and Vigilance

• Inspections: The IMA conducts an inspection program to ensure devices are maintained and used correctly according to the latest standards.
• Vigilance Reporting: The agency collects and evaluates reports of serious adverse incidents. Manufacturers, healthcare professionals, and users are required to report incidents that caused or could have caused serious harm or death.
• Corrective Actions: IMA has the authority to take measures such as product recalls, sampling, and testing to mitigate risks.

Registration and Licensing

• Economic Operators: Manufacturers, importers, and authorized representatives must register in the European database EUDAMED.
• Local Register: The IMA maintains a register of parties operating in Iceland that manufacture or are responsible for marketing medical devices.

Clinical Investigations

The IMA evaluates and authorizes applications for clinical investigations to ensure participant protection and scientific validity.

3. Language Requirements

To ensure user safety, instructions for use (IFU) must generally be in Icelandic. However, for professional use, English or another Nordic language (excluding Finnish) may be acceptable in specific cases. Implant cards must normally be provided in Icelandic.