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
Delegated Regulation (EU) 2025/1920, adopted by the European Commission on June 12, 2025, amends Regulation (EU) 2017/745 on medical devices with regard to the assignment of Unique Device Identifiers (UDI) to spectacle frames, spectacle lenses, and pre-assembled reading glasses.
The main objective is to optimize the traceability of these products while avoiding an excessive proliferation of UDIs for very similar products, given their many design variations.
The regulation introduces the concept of Master UDI-DI, allowing frames, lenses, or reading glasses with the same combination of essential design parameters—such as the horizontal width of the lens for frames, the spherical and addition power for lenses, and the width/power combination for ready-made reading glasses—to be grouped under a single identifier.
A new Master UDI-DI must be assigned as soon as a change in design parameters occurs.
These changes are intended to simplify data management in Eudamed, the European database for medical devices, while ensuring reliable identification and traceability.
Economic operators will need to adapt their internal systems as well as their printing and scanning technologies to comply with these new regulatory requirements.
The regulation will enter into force 20 days after its publication and will be applicable from November 1, 2028, although manufacturers may anticipate the assignment of Master UDI-DIs starting now.
This EU legislative text is directly applicable in all Member States.
