The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to improve the identification and traceability of medical devices. Manufacturers must assign UDI codes (Basic UDI-DI, UDI-DI, and UDI-PI) to most devices before placing them on the market and register key identifiers in the EUDAMED database. For highly individualised devices, such as spectacle frames, lenses, and ready-to-wear reading glasses, a Master UDI-DI is used to group similar products based on shared characteristics. Although all economic operators contribute to traceability, manufacturers are fully responsible for complying with UDI requirements.
The MDCG has updated their guidance with regard to the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this document, initially released in 2025, this document provides guidance on how to assign, label, and register the Master UDI-DI correctly.
A list of the changes can be seen below;
- Page 16: Diagram for “Master UDI-DI assignment scheme for spectacles lenses reflecting parameters and values ranges (assignment triggers)”: correction from “Advanced” to “Advanced/High”
- Page 18: Flowchart for “Decision trees for the assignment of Master UDI-DI” (for spectacle lenses): progression Advanced/High value corrected from “< 1,25 D” to “≥ 2.00 D
The updated guidance document can be accessed using the following link
