A user of a medical device is any person who uses the device, whether a healthcare professional or another user.

Owners and users are responsible for the safe use and maintenance of medical devices in accordance with applicable laws and guidelines.

Anyone who manufactures, sells, distributes, owns or uses medical devices and is aware of an incident, deviation, defect or malfunction that could cause or has caused harm to the health of a user, or their death, is obliged to report it to the Icelandic Medicines Agency (IMA).

Healthcare professionals, users and patients are encouraged to report all suspected incidents. IMA also encourages all owners of medical devices to report any incidents related to the use of a device to the economic operator of the device.

Instructions for use

As a general rule, medical devices intended for the general public must be accompanied by instructions for use in Icelandic.

Safety and quality requirements

CE marking confirms that a medical device meets all the safety and quality requirements laid down in European legislation.

The CE marking shows that the device has undergone a rigorous assessment and complies with requirements for design, manufacture and use. The marking is therefore a guarantee that the device is safe and suitable for use within the European Economic Area (EEA). To confirm the validity of a CE marking, the manufacturer should always be able to provide a declaration of conformity.

A declaration of conformity is an official document in which the manufacturer confirms that the device meets all the requirements set out in the relevant regulations. However, not all medical devices are CE-marked. This does not necessarily mean that they are illegal or unsafe.

Examples of devices that do not need to bear the CE marking are custom-made medical devices, systems and procedure packs, and medical devices used in clinical investigations. These exceptions are in accordance with the rules and ensure that the devices are nonetheless safe and lawful to use.

Owners of medical devices used on others

Owners of medical devices used on others can be of various kinds. Examples include ambulance services, hospitals, primary healthcare centres, beauty salons, etc. Such parties often own medical devices that are used to treat individuals who receive their services. Such owners bear legal responsibility for their medical devices in accordance with applicable laws and regulations on medical devices.

Under the Act on Medical Devices, No. 132/2020, and Regulation (EU) 2017/745 (MDR), individuals, legal entities or healthcare institutions that own or are responsible for the use of a medical device must ensure that certain conditions are met.