EU Extends Deadline for Master UDI-DI for Contact Lenses

Master UDI-DI, the European Union’s answer to creating UDI-DIs for Highly Individualized Devices, is a type of UDI-DI unique to the European Union. The Master UDI-DI technical solution aims to group highly individualised devices with specific similarities in terms of relevant design parameters under a common identifier to be assigned and registered in the UDI/Device registration module of Eudamed, thus relieving manufacturers, distributors and the Eudamed database from having too many identifiers assigned for similar devices.

This month the Medical Device Coordination Group (MDCG) published a guidance on using the Master UDI-DI: MDCG 2025-5, MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. This reinforced the required timelines of 9 November 2026 for contact lenses, and (11) September 2028 for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. However, this does not change the submission deadlines for Eudamed, which are expected to begin in early 2026 (pending a publication in the EU Official Journal; an upcoming blog will discuss this). The document “strongly encourages” manufacturers to take advantage of the Master UDI-DI as early as possible, despite the mandatory dates, and notes that Vigilance reports (when required) will need to be submitted using the Master UDI-DIs if they are assigned, also despite the mandatory dates.

Only weeks after this update recommending early adoption of Master UDI-DI by the MDCG, the European Commission published a new Delegated Regulation (EU) 2025/788 that pushes the date for contact lens Master UDI-DI a year, to 9 November 2026. The reason given is that MDCG 2024-14, Guidance on the implementation of the Master UDI-DI solution for contact lenses, published in November 2024, is crucial enough to manufacturers and was published late enough with respect to the deadline to give them an additional year to meet the obligations.

It seems unusual that the MDCG would be strongly recommending that manufacturers implement early at the same time that the European Commission would be pushing the mandatory deadline further out, but rest assured that we will publish any updates as they occur!