The EU Commission has published the draft regulation regarding the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. The aim of this regulation is to resolve the implementation issue concerning the registration of UDI-DI data elements in EUDAMED for the mentioned devices, similar to what was done for contact lenses.
The amendment provides guidelines for the assignment of UDI-Dis as per the following:
Spectacle Frames
The UDI-DI shall be assigned to spectacle frames that have the same combination of design parameters, including at least the horizontal boxed lens size which would be the Master UDI-DI. A new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters.
Spectacle Lenses
The UDI-DI shall be assigned to spectacle frames that have the same combination of design parameters, including at least groups of mean sphere (spherical equivalent power), groups of addition power and groups of similar vision impairments, which would be the Master UDI-DI. A new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters.
Ready-to-wear reading spectacles
The UDI-DI shall be assigned to spectacle frames that have the same combination of design parameters, including at least the horizontal boxed lens size and lens spherical power, which would be the Master UDI-DI. A new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters.
The draft regulation can be accessed using the following link
