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.

L’article NEORIS products and CE marking est apparu en premier sur Neoris.

NEORIS products have been specially designed and developed to meet the specific needs of aesthetic keratopigmentation, as requested and driven by pioneering surgeons in this field, particularly Dr. Ferrari.

The main demands were to avoid:

• endothelial cell loss, to guarantee a high level of safety for the beneficiary of keratopigmentation

• color change over time

To meet these requirements, product ingredients must:

• avoid inflammatory or toxic reactions in the eye

• be stable to heat, humidity and UV light

In addition, products must create a natural, uniform appearance, taking into account natural variations in iris color to avoid an artificial look.

For these reasons, formulations developed by Neoris are free from:

• Controversial ingredients

• Nanoparticles

• Preservatives

• pH regulators

These formulations do not contain:

– Iron hydroxide: nanoparticle & unstable over time

– Iron (II,III) oxide: unstable over time

– Chromium hydroxide: this substance is prohibited for certain medical or cosmetic applications in certain countries, and is unstable over time

– Sodium hydroxide and lactic acid: corrosive

– Phthalates from packaging: endocrine disruptors

The packaging (pharmaceutical-grade brown glass) and sterilization method (gentle steam sterilization) have also been chosento preserve product quality.

Thanks to their unique composition and manufacturing process, Neoris products:

• Preserve endothelial cells

• Have high covering power

• Maintain stable color over time

L’article Ingredient of NEORIS product est apparu en premier sur Neoris.