EU MDCG 2024-14 Rev.1 Guidance on Master UDI-DI for Contact Lenses: 2025 Update

The European Commission’s MDCG 2024-14 Rev.1 (August 2025) updates the guidance on the implementation of the Master UDI-DI solution for contact lenses. Triggered by Regulation (EU) 2025/788, this revision changes the application timeline to 9 November 2026 and adds new references to MDCG 2025-7 and the Commission’s webpage on Master UDI-DI for highly individualised devices. These updates provide manufacturers with more time and clarity to prepare for EU medical device compliance.

Key Updates in MDCG 2024-14 Rev.1 (2025)

The revision introduces three notable changes:

• Extended deadline: Application of Master UDI-DI for contact lenses now required from 9 November 2026 instead of 2025.

• Legal alignment: Explicit reference to Regulation (EU) 2025/788, which amended Delegated Regulation (EU) 2023/2197.

• Additional guidance references: Inclusion of MDCG 2025-7 Position Paper and the Commission’s webpage on highly individualised devices, giving manufacturers further interpretive tools.

What Remains Unchanged in the Guidance

Despite these updates, the core guidance remains stable:

• Definitions and terminology: Master UDI-DI, Basic UDI-DI, UDI-PI.

• Assignment rules: Differentiating between standard and made-to-order contact lenses.

• Labelling requirements: Including AIDC and HRI examples from GS1 and HIBCC.

• Packaging rules: Application of Master UDI-DI across single-use packs and grouped containers.

• Eudamed registration: Master UDI-DI remains the key identifier.

• Vigilance reporting: UDI must accompany incident reports; legacy devices can still use Eudamed IDs.

Impact on Manufacturers and Market Access

The extended deadline has important consequences:

• Extra time for compliance: An additional year allows companies to test data capture systems, update labelling workflows, and align regulatory teams.

• Stronger consistency: References to other MDCG papers reduce conflicting interpretations across product categories.

• Voluntary early adoption: While optional until 2026, manufacturers who comply earlier may gain smoother Eudamed integration and regulatory confidence.

Compliance Actions Before November 2026

To take full advantage of the extended transition period, manufacturers should:

• Map product families: Reassess grouping rules for standard vs. made-to-order lenses.

• Update labelling systems: Ensure barcodes and human-readable information include the correct Master UDI-DI.

• Prepare Eudamed entries: Register devices in alignment with updated UDI requirements.

• Train teams: Ensure regulatory, IT, and quality staff understand the revised rules.

• Audit vigilance processes: Verify that incident reporting aligns with Master UDI-DI.

Internal Links  

• EU Medical Device Classification & Regulation (MDR/IVDR)

External Links (official sources)

• MDCG 2024-14 Rev.1 Guidance PDF

MDCG 2024-14 Rev.1 (August 2025) updates EU guidance on Master UDI-DI for contact lenses. Regulation (EU) 2025/788 postpones the deadline to 9 November 2026. The revision adds references to MDCG 2025-7 and the EU webpage on Master UDI-DI for highly individualised devices. Core rules on assignment, labelling, vigilance, and Eudamed registration remain unchanged. Manufacturers should use this extended timeline to prepare compliance processes for EU medical device regulation.

‍