The only pigments for aesthetic keratopigmentation

Why CE-marked pigments cannot be promoted for aesthetic keratopigmentation in the EU?

In the European Union, pigments used for keratopigmentation must comply with strict regulations, especially when it comes to their intended use, whether for medical or aesthetic purposes (i.e. Reach).

While some products on the market have received CE marking under the former Medical Device Directive (93/42/EEC), this does not mean they are authorized for aesthetic eye color change.

❌ Aesthetic keratopigmentation is not covered by EU Medical Device Regulation

The Medical Device Regulation (EU) 2017/745 (MDR) applies to devices with a medical purpose (Article 1(1)) and to certain non-medical products listed in Annex XVI (Article 1(2)).

However, aesthetic keratopigmentation is not listed in Annex XVI, and no common specifications exist for this type of product under Implementing Regulation (EU) 2022/2346.

👉 As clarified in the official guidance: “Products for keratopigmentation – Not covered by the [common specifications]. If intended for the treatment of disfiguring corneal opacities the products qualify as medical devices.” (MDCG 2023-5, page 8)

This means:

  • CE-marked pigments may be legally used only for medical indications (e.g., treating corneal disfigurements).
  • Eye color change for cosmetic purposes is excluded from the CE marking framework.

⏳ “But some products still have a valid certificate…” — Yes, but only for medical use

Some CE-marked medical pigments benefit from the transitional provisions of the MDR (extended by Regulation (EU) 2023/607) and can stay on the market until 31 December 2027 — but only for their certified medical purpose.

Even during this transition:

  • Their CE mark is valid for medical purposes, not for eye color change
  • Marketing them for aesthetic keratopigmentation is inappropriate. They are not in the scope of EU law.
  • Claiming medical CE marking does not provide any additional safety for aesthetic use.

✅ Neoris: the only products specifically designed and marketed for aesthetic keratopigmentation

Because CE-marked pigments are limited to therapeutic indications, they cannot be positioned or sold for eye color change (aesthetic keratopigmentation). This regulatory gap means that no CE-marked pigment competes in the aesthetic segment.

Neoris pigments, by contrast, are:

  • Openly and transparently positioned for aesthetic eye color change,
  • Supported by dedicated safety assessments
  • The only pigments designed specifically for aesthetic keratopigmentation

CE-marked medical devices are legally certificated to therapeutic use only.

If you are seeking pigments for aesthetic eye color change, Neoris products remain the only solution for professionals practicing aesthetic keratopigmentation in Europe.

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