The Icelandic Medicines Agency (IMA) carries out surveillance of medical devices, their safety and their correct use.

The aim of surveillance is to prevent harm to patients and to ensure that the manufacture, maintenance and use of medical devices are in line with the best professional knowledge at any given time.

Surveillance refers, on the one hand, to market surveillance, i.e. surveillance to ensure that medical devices placed on the market in Iceland meet the requirements for safety, performance and labelling. On the other hand, it refers to supervision to ensure that medical devices are maintained and that their use is monitored.

Manufacturers, importers, distributors, sellers, owners, operators and users of medical devices shall provide such assistance and information as is necessary and requested at any given time.

A medical device may only be placed on the market or put into service if it complies with applicable laws and regulations.

Enquiries and notifications can be sent via Contact us.