EC | Master UDI-DI Introduced for Highly Individualized Medical Devices

Syafina Y. June 28, 2025
The European Commission (EC) has introduced a targeted solution for highly individualized medical devices under the Unique Device Identification (UDI) system, known as the Master UDI-DI. This approach aims to simplify UDI assignments for groups of similar products such as contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

The UDI system forms part of the EU’s regulatory framework under MDR and IVDR, enhancing traceability, post-market monitoring, and patient safety.

What is Master UDI-DI?

The Master UDI-DI is a newly introduced identifier used for a group of similar devices that share defined clinical and non-clinical characteristics. Instead of assigning individual UDI-DIs to each configuration, manufacturers can now group certain products under a single Master UDI-DI, reducing the data burden in the UDI database.

This solution currently applies to:
  • Contact lenses
  • Spectacle frames
  • Spectacle lenses
  • Ready-to-wear reading spectacles

Key Documents and Regulatory Instruments

You may refer to the following documents for the implementation of the Master UDI-DI solution:

Contact Lenses:

Spectacle Frames, Lenses, and Reading Spectacles:
  • Commission Delegated Regulation (EU) .../... of 12 June 2025 (under scrutiny)
  • MDCG 2025-XX Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles (under development)

See also MDCG 2025-XX Position Paper: Timelines of the implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles (under development).

UDI System at a Glance

Under Articles 27 of 2017/745 and 24 of 746/2017, the UDI system includes:
  • Assignment of UDI-DI (device identifier) and UDI-PI (production identifier)
  • Labelling requirements on devices or packaging
  • Storage of UDI by economic operators, health institutions and healthcare professionals
  • Establishment of an electronic system for UDI (UDI database)

The Basic UDI-DI continues to serve as the main access key for certificates, declaration of conformity, technical documentation and summary of safety and clinical performance.

UDI Issuing Entities

The EC has designated four entities, renewed until 27 June 2029, to issue UDIs:

Each issuing entity maintains its own UDI HRI & AIDC formats and basic UDI-DI formats, which are periodically updated.

See also:

Published by European Commission on 12 June 2025