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MDR and Lasers for Tattoo Removal. Regulation (EU) 745/2017
Tattoos are increasingly common among people of all ages. They come in colors, black and white, large, small, etc., all made with ink and very specific instruments to achieve the best result in the safest possible way. To date, both the manufacture of inks and the instruments to create them are regulated by each EU country, meaning there is no common CE marketing regulation for them. However, this changes for tattoo removal lasers. These are regulated by Regulation (EU) 745/2017 on medical devices or MDR.
The MDR, the law that must be followed for CE Marking
This means that, while not considered medical devices, they must comply with the requirements of a law that regulates medical devices. The MDR is the law that determines what must be met to market, among others, a Tattoo Removal Laser with CE Marking.

Tattoo removal lasers are reflected in Annex XVI of the MDR. In addition, they must comply with Common Specifications published by the European Commission, although to date, these Common Specifications have only been published as a draft. It is estimated that the final versions will be published between July and December 2022.

These Common Specifications indicate, among other things, how the risk assessment of these devices should be carried out and all the related documentation that must be generated.