UDI-DI Timelines Contact Lenses and Spectacles

Understanding MDCG 2025-7 — Master UDI-DI Implementation Timelines for Contact Lenses and Spectacles

In July 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-7, clarifying the phased implementation of the Master UDI-DI requirement under the EU MDR for highly individualised medical devices such as contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

The Master UDI-DI system, introduced under Annex VI Part C of Regulation (EU) 2017/745 and amended by Delegated Regulations 2023/2197 and 2025/…, allows manufacturers to group products with similar design characteristics under a common UDI identifier. This streamlines the traceability process and reduces the burden on Eudamed by avoiding excessive UDI-DI entries for products with minor variations.

Key implementation deadlines outlined in MDCG 2025-7 include:

• UDI Labelling:

  • Class IIa/IIb: Required since 26 May 2023

  • Class I: Required from 26 May 2025

• Eudamed UDI/Device Registration Module:

  • Mandatory use from Q1 2026, six months after its functionality is officially announced in the OJEU.

• Master UDI-DI for Contact Lenses:

  • Required from 9 November 2026

  • Voluntary assignment can begin earlier.

• Master UDI-DI for Spectacle Frames, Lenses, and Ready-to-Wear Reading Spectacles:

  • Required from September 2028

MDCG encourages early voluntary assignment of Master UDI-DIs. Once assigned, manufacturers must immediately label devices accordingly and register them in Eudamed. Notably, the Master UDI-DI will also be used for vigilance reporting from Q3 2026, even if its mandatory implementation date has not yet arrived.

🔗 Full position paper: MDCG 2025-7 PDF

Need help implementing UDI or acting as your EU Authorized Representative?

At AF Pharma, we offer full regulatory support for manufacturers entering the EU market. As your EU Authorized Representative, we ensure compliance with UDI, Eudamed, labelling, and post-market obligations under the EU MDR. Our services include:

• Acting as your official point of contact with EU authorities

• Reviewing and submitting Eudamed registrations

• Managing vigilance and PMS communications

• Supporting documentation, labelling, and traceability requirements

💼 Learn more and appoint us today:👉 AF Pharma – EU Authorized Representative Services