The MDCG has recently published a guidance document regarding the implementation of the Master UDI-DI solution for contact lenses. To offer some background to this document, the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR), is designed to ensure robust identification and traceability of medical devices. Manufacturers must assign Basic UDI-DIs, UDI-DIs, and UDI-PIs to all devices (excluding custom-made devices) before their placement on the market, following the rules established by designated issuing entities.
To further enhance traceability, manufacturers are required to register Basic UDI-DIs and UDI-DIs in the European Database on Medical Devices (EUDAMED). For contact lenses, which are considered highly individualised devices, the MDR—amended by Commission Delegated Regulation (EU) 2023/2197—requires the assignment of a Master UDI-DI, as specified in Annex VI, Part C, Section 6.6.1. While all economic operators play a role in ensuring traceability under Article 25 of the MDR, the primary responsibility for proper identification and traceability rests with the manufacturer.
This document provides guidance on implementing Master UDI-DI rules for contact lenses, focusing on their structure, assignment, labelling, and registration in EUDAMED.
The document can be accessed using the following link
