Master UDI-DI for spectacle frames and lenses

On 23 September 2025, the Official Journal of the EU published Commission Delegated Regulation (EU) 2025/1920. This Regulation amends Part C of Annex VI of the EU Medical Devices Regulation, by introducing provisions for assigning Master UDI-DI to spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

Master UDI-DI for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles

Spectacle frames

• A Master UDI-DI must be assigned to frames sharing the same design parameters, including at least the horizontal boxed lens size.
• Any change in these design parameters will trigger a new Master UDI-DI.

Spectacle lenses

• A Master UDI-DI is assigned to lenses with the same combination of design parameters, including at least groups of mean sphere (spherical equivalent power), groups of addition power and groups of similar vision impairments.
• A new identifier is necessary whenever one of these parameters changes.

Ready-to-Wear reading spectacles

• A Master UDI-DI is assigned to products sharing same combination of design parameters, including at least horizontal boxed lens size and lens spherical power.
• Changes in these parameters require a new Master UDI-DI.

Implementation timeline

The new requirements apply from 1 November 2028. However, manufacturers may already assign Master UDI-DIs voluntarily before this date, as strongly encouraged by the MDCG.

Master UDI-DI: a unique identifier to group devices

The Master UDI-DI is a unique identifier used to group highly individualised medical devices that share specific clinically relevant parameters (e.g., contact lenses with the same base curve and diameter). The assignment of a Master UDI-DI follows EU-designated issuing entity rules and must be linked to a Basic UDI-DI.

Do you have questions on UDI obligations? Contact us here or at mdlaw@obelis.net.

References:

European Commission (2025). Commission Delegated Regulation (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Retrieved on 23/09/2025.