Background:
Endorsed by the Medical Device Coordination Group (MDCG) in August 26, 2025, MDCG 2024-14 Rev. 1 offers practical guidance for implementing the “Master UDI-DI” solution for contact lenses under the EU Medical Devices Regulation (MDR).
Purpose:
This document helps manufacturers navigate the Master UDI-DI framework by clarifying assignment rules, labeling requirements, and links to Commission Delegated Regulation (EU) 2025/788 and consolidated MDR texts.
You may access the document and download it from our website.
Source: MDCG