Medical Devices
Medical Devices
IMA monitors and ensures compliance with medical device legislation in Iceland. The goal of the surveillance is to prevent patient harm and to ensure that production, maintenance and use of medical devices is according to latest standards and guidelines.
Laws and regulations
Laws and Regulations on Medical Devices
Clinical investigationsBefore starting a clinical investigation of a medical device, the sponsor must determine if the investigation is subject to application, notifification or neither to the Icelandic Medicines Agency (IMA)
Registration of distributersDistributors of medical devices who are responsible for the marketing of such devices in Iceland must register with the Icelandic Medicines Agency (IMA).
The general rule is that instructions for use shall be in Icelandic
