We hereby inform you that pigment suspensions for keratopigmentation for aesthetic purposes (of which NEORIS products are a part) cannot, under any circumstances and on any legal basis, benefit from CE marking under medical device regulations:
• The European regulation on medical devices (Regulation 2017/745) is not applicable to this type of product, as it does not meet the definitions of either a medical device or an aesthetic product as set out in Annex XVI of the regulation
• Since May 27, 2024, pigment suspensions for aesthetic keratopigmentation previously subjected to the old Directive93/42/EEC no longer receive CE marking as medical devices.
The National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed that these products are now subject to Directive (EU) 2001/95/EC concerning general product safety and do not fall under any other specific regulation.
For CE-marked products intended for medical purposes, health authorities evaluate the benefit/risk balance for the patient. It is therefore natural to accept a level of risk for the patient, given the therapeutic benefit they may receive. Consequently, it is not advisable to use a CE-marked product to perform aesthetic keratopigmentation. Using CE-marked pigments for aesthetic keratopigmentation does not provide additional protection from an insurance perspective. In fact, professionals could be criticized for using them outside of their intended purpose, and it is now scientifically proven that they expose keratopigmentation recipients to an increased risk of endothelial cell loss.
Indeed, aesthetic products must not present a risk to the user. For this reason, and in accordance with Directive (EU) 2001/95/EC,
NEORIS has had all its products evaluated by the toxicologists at Eurofins laboratory, who concluded that there is no risk to the user.
