People tattoo themselves since antiquity, in many different cultures and for different reasons people have always been beautified. As humanity has evolved, machines have evolved and the cult has changed. From the art, which should look only good, up to the history of humans on the body. Also the knowledge about the health consequences has increased.
Therefore the national and international legal requirements for tattoo machines and instruments as well as for commercial paint material products are constantly increasing. A specific regulation on tattoo colours injectable into the skin does not yet exist in the European Union. The European Commission (EC) has recognised the need for a harmonised regulation to improve the safety of tattoo paints and market surveillance by regulatory authorities.
In addition to the official Plan A for the future regulation of tattoo and permanent make-up colours with a restriction dossier according to Annex XV of the REACH Regulation, the EC has initiated another Plan B for the regulation of tattoo colours and tattoo equipment according to the new Medical Devices Regulation (MDR). In contrast to the former Medical Devices Directive (MDD), the scope of the MDR covers products without a medical purpose, including tattoo products. These are currently explicitly excluded from the scope of the MDR, indicating that they have at least been considered for inclusion.
Cheyenne has a leading role in finding a solution and by producing under medical standards we achieve the exact requirements that must prevail.
Here is the current presentation of our Quality Manager at the ECTP 2019 in Switzerland.
