New MDCG Guidance on the Implementation of the Master UDI-DI Solution for Spectacle Frames, Spectacle Lenses, and Ready-to-Wear Reading Spectacles

The Medical Device Coordination Group (MDCG) recently released a new guidance, MDCG 2025-8, “Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles,” which aims to provide guidance in the implementation of Master UDI-DI rules for spectacle frames, spectacle lenses and ready-to-wear reading spectacles with regards to its structure, assignment, labelling and registration in EUDAMED.

Master UDI-DI Implementation Timeline:

09/23/2025 - Commission Delegated Regulation (EU) 2025/1920 on Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles was published in the Official Journal of the European Union (OJEU).

10/13/2025 - Commission Delegated Regulation (EU) 2025/1920 on Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles was entered into force.

11/01/2028 - Assignment of Master UDI-DI to spectacle frames, spectacle lenses and ready-to-wear reading spectacles labelling becomes mandatory, providing a three-year transitional period from its entry into force.

Spectacle frames, spectacle lenses, and ready to wear reading spectacles produced prior to November 1st, 2028 are not required to have a Master UDI-DI on the label.

Link to guidance: MDCG 2025-8 Guidance

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