EC | Timelines Confirmed for Master UDI-DI Implementation to Optical Medical Devices

Syafina Y. July 26, 2025
The European Commission’s Medical Device Coordination Group (MDCG) has released a new position paper clarifying the timeline for implementing the Master UDI-DI system specifically for highly individualized optical devices, namely, contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

The Master UDI-DI is a technical solution designed to simplify the identification and registration of medical devices that share similar characteristics but differ slightly between units, making full individual UDI-DIs impractical. This position paper builds on previous guidance and legislative updates by outlining key implementation dates and encouraging manufacturers to act early.

Key Dates to Note

  • UDI Labelling Requirements:
    • For Class IIa (short-term use) or IIb (long-term use) corrective contact lenses: effective 26 May 2023
    • For Class I devices (i.e., spectacle frames, lenses, and ready-to-wear reading spectacles): effective 26 May 2025
  • Mandatory Use of Eudamed UDI/Device Registration Module:
    • Expected from Q1 2026, pending official confirmation of module functionality
  • Implementation of Master UDI-DI:
    • Contact Lenses: mandatory from 9 November 2026
    • Spectacle frames, lenses, and ready-to-wear reading spectacles: mandatory from September 2028

What Should Manufacturers Do Now?

While these deadlines may seem distant, the MDCG strongly encourages manufacturers to voluntarily assign Master UDI-DIs ahead of the mandatory dates. Early adoption will streamline Eudamed registration, avoid future bottlenecks, and ensure smoother transition once the system is fully enforced.

Additionally, once Eudamed’s vigilance and post-market surveillance module becomes mandatory (expected Q3 2026), the Master UDI-DI should also be used when reporting adverse events, even if the full implementation date hasn’t yet passed.

For further context on the Master UDI-DI concept and its significance, you may refer to this earlier blog post:

For full technical details, including references to relevant EU regulations and the implementation timelines, you can view the full MDCG 2025-7 Position Paper here:

Published by European Commission on 10 July 2025