Substances, combinations of substances or items intended for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing, fall within the definition of medical devices without an intended medical purpose.

Caution should be exercised when using these medical devices, and the purchase of falsified products should be avoided. The Icelandic Medicines Agency (IMA) highlights the following risks associated with buying falsified fillers.

How can falsified products be avoided?

Where can known or suspected falsified products be reported?

Known or suspected falsified products that fall within the definition of medical devices without an intended medical purpose can be reported to IMA by email at medical.devices@lyfjastofnun.is.

Further information on fillers for cosmetic use

Substances, combinations of substances or items injected under the skin for cosmetic filling are medical devices in the highest risk class, Class III. When placed on the market, they must have an EU declaration of conformity in which the manufacturer confirms that the devices meet the requirements of the Medical Devices Regulation. As these are Class III medical devices, a notified body must be identified in the EU declaration of conformity. The CE marking must appear on the medical device and its packaging. The notified body’s four-digit identification number must also appear alongside the CE marking on the packaging.