Master UDI-DI regulations for spectacle frames, spectacle lenses and ready-to-wear spectacles published!

[2025-09-23] (Open access) Delegated Regulation (EU) 2025/1920 on the unique identification of optical medical devices (spectacle frames, spectacle lenses and ready-to-wear reading spectacles) was published in the Official Journal of the European Union on September 23, 2025. It follows the public consultation we reported on earlier this year. We invite you to read our article, written on this occasion, to understand what the “Master UDI-DI” consists of for these “highly individualized” devices.

Mandatory application in 2028

Spectacle frames, lenses and ready-to-wear spectacles will have to have a master IUD-ID by November 1, 2028 at the latest. This identifier will be needed to register these devices in the European medical device database(EUDAMED). For the record, EUDAMED will be mandatory in 2026.

To find out more about the details of the transition, which is due to start soon, we invite you to read our July article.

Article written by Muriel Gonidec, President of DM Experts SAS

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