EC Legislation
(source : MarquageCE : ANSM response)
Question dated 11/20/2012 :
Hello,
Please allow me to send this message jointly to our ANSM and DGCCRF contacts so that the information can be confirmed by your respective departments.
Following a question raised locally by one of our supplier members, several government departments (particularly the DDPP) have issued the following statement:
Tattoo needles and their holders (nozzles), which are intended to introduce dye substances into the surface of the human body through breaking the skin, and are not intended for medical purposes, are NOT medical devices within the meaning of the Health Code and therefore cannot be CE marked.
However, we can note three things
1° Some suppliers market this type of equipment with the CE mark, and sometimes display this wording as an advertising argument;
2° Some local authorities, such as the ARS during inspections, encourage tattooists to use CE-marked equipment;
3° Most tattoo practitioners therefore request, in good faith, CE-marked equipment, while it is basically, if we understand correctly, an irregular marking concerning needles and their holders.
Consequently, and with the aim of informing as accurately as possible all our professional members, tattoo practitioners and suppliers, as well as all non-member tattoo practitioners, we ask you to confirm (or rectify, if necessary) the above remark.
ANSM response dated 01/18/2013 :
From [...] of the Therapeutic and Cosmetic Medical Devices Department, ANSM:
I am following up on your request of November 20, 2012 regarding your question on needles (and their holders) intended to introduce dye substances that can be CE marked for skin penetration.
1) Response to Question 1:
I remind you that medical devices are regulated by Directive 93/42/EC. This directive governs the placing on the market of medical devices, the purpose of which is indicated on the package leaflet and labeling.
CE Marking Tattoo Products and Materials - ANSM Analysis January 2013 - Page 1/2
The purposes of a medical device are generally diagnostic, therapeutic, preventive, treatment control, alleviation of disease, compensation for an injury, handicap, change in anatomy, physiological process...
So this directive provides a framework for the purposes for which the medical device is developed, but it does not provide a framework for the uses that can be made of this medical device.
In your case, two cases can be distinguished: the use of needles for so-called "medical" tattooing and for so-called "cosmetic" tattooing:
- in case tattoo needles are intended for medical use, the CE logo for compliance with the European Directive 93/42/EC on medical devices appears on the primary or secondary packaging such as labels. Medical use covers, in particular, tattooing of the breast areola as part of breast reconstruction and targeting during radiation therapy.
- In cases where tattoo needles are not intended for medical use and are therefore intended for cosmetic use, primary or secondary packaging, such as labels, may not bear the CE logo indicating compliance with European Directive 93/42/EC on medical devices.
This rule also applies to packaging of other materials intended for tattoos.
This means that the purpose of a medical device and its use are not connected. There is nothing in the legislation that prevents a tattoo artist who performs cosmetic tattoos from purchasing and using CE-marked equipment
.
The supplier's advertising around CE-marked needles is not objectionable as long as the technical file and documentation for these needles concern needles intended for "medical" tattooing, even though these same needles may be used for cosmetic purposes. However, in this case, the supplier cannot limit his advertising message to cosmetic purposes only.
2) Response to finding 2:
The ARS is trying to recommend the use of CE-marked needles as a guarantee of product quality and safety. This position on the choice of equipment to use may seem like an option to the extent that such equipment exists. However, limiting the tattoo needle market to CE-marked products under European Directive 93/42/EC seems too simplistic, as there may be very good quality tattoo needles specifically intended for cosmetic use.
3) Response to comment 3:
If the CE marking on the needles was done in accordance with Directive 93/42/EC, this is not an irregular CE marking.
As stated in response 1, the tattoo artist is free to use the needles he or she wishes, with or without CE marking.
To summarize:
Only products and materials qualified as "medical devices" can be labeled as "CE";
A priori, with regular suppliers, medical device qualification is a cumbersome and expensive process, so most products and materials they sell MUST NOT be labeled as CE.
However, a tattoo artist can use these (non-CE) products and materials just as much as CE products and materials.