❌ 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.