The MDCG has released a position paper regarding the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
To offer some background to this position paper, the introduction of the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical devices (the MDR), is designed to ensure proper identification and traceability of medical devices. Manufacturers must assign Basic UDI-DIs, UDI-DIs, and UDI-PIs to all devices (excluding custom-made devices) in accordance with the rules set by the designated issuing entities before these devices are placed on the market. To enhance traceability, manufacturers are also required to register Basic UDI-DIs and UDI-DIs in the UDI/Device registration module of the European Database on Medical Devices (EUDAMED).
For devices that are highly individualised, such as contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles, the UDI-DI assignment criteria will be adjusted. A ‘Master UDI-DI’ has been introduced as per Annex VI, Part C, Sections 6.6.1 and 6.6.2 of the MDR, as amended by Commission Delegated Regulation (EU) 2023/2197 concerning Master UDI-DI for contact lenses, and by Commission Delegated Regulation (EU) 2025/788 concerning Master UDI-DI for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. The Master UDI-DI aims to group highly individualised devices with similar design characteristics under a common identifier, simplifying the process for manufacturers, distributors, and EUDAMED by reducing the number of identifiers required for similar devices. The technical solution for Master UDI-DIs is currently being developed by the EU UDI issuing entities.
According to the MDCG 2021-24 Guidance on the classification of medical devices, corrective contact lenses are classified as Class IIa (short-term use) or Class IIb (long-term use) medical devices, while spectacle frames, spectacle lenses, and ready-to-wear reading spectacles are classified as Class I medical devices.
This MDCG Position Paper aims to clarify the timelines for implementing the Master UDI-DI for the aforementioned devices, as specified in the relevant Delegated Regulations. It also addresses the requirement to label the Master UDI-DI, the use of the UDI/Device registration module of EUDAMED, and the interrelationship between these obligations.
The position paper can be accessed using the following link
