European Commission adopts delegated act on Master UDI-DI for spectacle products
The European Commission adopted on 12 June 2025 a delegated act amending Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), to introduce the Master UDI-DI solution for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. This solution, which already covers contact lenses, uses a single identifier, the Master UDI-DI, to represent certain devices with high individualisation, instead of assigning standard unique device identification (UDIs) to each device individually. The delegated act is currently under a scrutiny period and will be published afterwards. Additionally, a Medical Device Coordination Group guidance document is being developed to outline the implementation timelines for the Master UDI-DI concerning spectacle frames, spectacle lenses, and ready-to-wear reading spectacles and provide practical details for manufacturer.s