1st revision of MDCG 2024-14 guidance on the Master UDI-DI solution for contact lenses

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 and guidance MDCG 2022-6, and to introduce clarifications and examples of what is to be considered as a significant change or not.

The MDCG has released its first revision of its guidance on the Master UDI-DI, providing manufacturers of contact lenses with detailed instructions on grouping, labelling, vigilance, and EUDAMED registration.

Key updates introduced in this revision:

• Clarification of the criteria for grouping contact lenses under a Master UDI-DI;
• Additional guidance on the use of attributes such as material, water content, diameter, and base curve in defining device groups;
• Expanded explanations on the assignment of Basic UDI-DI versus Master UDI-DI for contact lenses;
• Clarifications on the relationship between the Master UDI-DI solution and regulatory requirements under MDR;
• Inclusion of practical examples to illustrate grouping approaches;
• Revised annexes to better support manufacturers in preparing and submitting their UDI-related information in EUDAMED;
• Confirmation of the implementation date: Master UDI-DI assignment becomes mandatory from 9 November 2026 (with the option of voluntary early compliance).

This revision provides manufacturers with the tools needed to ensure compliance, improve traceability, and prepare for the upcoming mandatory deadline

DOWNLOAD THE MDCG 2024-14 Rev.1