Icelandic Medicines Agency
Fillers, rules and labelling
Fillers are classified as medical devices and are therefore supervised in accordance with the Act on Medical Devices of 2020. The aim of the supervision is, among other things, to increase user safety and prevent harm resulting from the use of the devices.
Further definition of fillers, medical devices without a medical purpose
Substances, combinations of substances or objects that are injected or otherwise placed in or under the skin, in muscle or in other tissue to change appearance, but without a specific medical purpose. Tattoo ink is not included.
It is important for individuals intending to receive filler treatment to familiarise themselves with the rules, including who is authorised to provide such treatment, and thereby ensure their own safety.
Rules, supervision and labelling of fillers
Doctors with a specialist licence in dermatology or plastic surgery may administer fillers at a healthcare professional's practice, as may other doctors, dentists and nurses if they meet the requirements regarding knowledge and facilities. In addition, valid insurance under the Act on Patient Insurance is required in order to provide filler treatment to change appearance.
There are no specific rules on who may purchase fillers, but purchases are presumably limited by who may use them.
It is prohibited to provide filler treatment to individuals under the age of 18. Before treatment begins, the person receiving the treatment must be given written and oral information and their informed consent must be obtained, with a reflection period of at least 48 hours. The treatment area must also be photographed before and after treatment.
Requirements and CE marking
Fillers must in all cases meet the requirements set out in laws and regulations on medical devices. These include that all medical devices must bear the CE marking and be accompanied by a valid EU declaration of conformity, in which the manufacturer declares that the requirements of the applicable regulations have been complied with in the manufacture of the medical device.
The CE marking indicates that a medical device has been assessed by a notified body and found to meet the safety, health and environmental protection requirements applicable in Europe. Such marking is necessary for a device to be placed on the market, sold and used in Europe.
Distributors are required to ensure that the rules on CE marking and the EU declaration of conformity are complied with.
IMA's supervision
The Icelandic Medicines Agency (IMA) supervises the legality of medical devices, including fillers, under the Act on Medical Devices, No. 132/2020.
The Act on Medical Devices covers, among other things, the manufacture, import, distribution, sale, placing on the market, market surveillance, maintenance and use of medical devices, and their supervision. Supervision may be random or in response to reports.
The agency's powers extend to supervising that a medical device meets the requirements that apply to it and that its use is in accordance with its intended purpose, e.g. under the manufacturer's instructions, regulations, laws and other rules on medical devices.
When supervising medical devices, including fillers, IMA is authorised to enter premises where medical devices are located. This may include manufacturing sites, points of sale for both wholesale and retail, or other premises where medical devices are used, e.g. beauty salons.
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 IMA under the Act on Medical Devices.
In addition, anyone who has information about incidents or deviations related to medical devices is encouraged to send a report to IMA.
Directorate of Health supervision of filler treatment
The Directorate of Health supervises healthcare services, including practices where filler treatment to change appearance is provided. Those intending to provide such services are required by law to notify the Directorate of Health and obtain its confirmation that the practice meets professional requirements.
Filler treatment may only be provided by certain healthcare professions, in accordance with the regulation on restrictions on appearance-altering treatments with fillers.