Revised MDCG Position paper concerning timeline for implementation of Master UDI-DI for contact lenses and spectacle frames

The Medical Device Coordination Group (MDCG) has published its revised position paper, MDCG 2025-7 Rev. 1, concerning timelines of implementation of Master UDI-DI in relation to contact lenses and spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. The purpose of the revision is to clarify the dates by which implementation of the Master UDI-DI and use of the UDI/Device registration module of EUDAMED become obligatory for these devices. The dates are:

• placement of UDI carriers on the label of the device and on all higher levels of packaging will become obligatory for Class IIa and Class IIb devicesfrom 26 May 2023 ;

• placement of UDI carriers on the label of Class I devices and on all higher levels of packaging will become obligatory from 26 May 2025 ;

• use of the UDI/Device registration module of EUDAMED will become mandatory from 28 May 2026 ;

• the Master UDI-DI assignment solution must be implemented by manufacturers of contact lenses from 9 November 2026 ;

• the Master UDI-DI assignment solution must be implemented by manufacturers of spectacle frames, spectacle lenses, and ready-to-wear reading spectacles from 1 November 2028.

The position paper provides that manufacturers of eyewear falling within its scope are “strongly encouraged to make use of the voluntary assignment of Master UDI-DI before the mandatory dates of application in due time, to be able to take advantage of the features offered by the Master UDI-DI assignment solution”.