Timelines for the Introduction of the Master UDI-DI

MDCG Publishes Timelines for the Introduction of the Master UDI-DI for Eyewear and Contact Lenses

The Medical Device Coordination Group (MDCG) has released its MDCG 2025-7 position paper, setting out the official timelines for the implementation of the Master UDI-DI for highly individualised medical devices, including:

• Contact lenses

• Spectacle frames

• Spectacle lenses

• Ready-to-wear reading spectacles

Background

The Master UDI-DI is a new identification concept for highly individualised products. It allows similar devices with identical design characteristics to be grouped under a single identifier in EUDAMED.
The aim is to reduce the number of UDI records and simplify management for manufacturers, distributors, and authorities.

Key Deadlines at a Glance

Voluntary Implementation Encouraged

Manufacturers are allowed – and encouraged – to assign Master UDI-DIs before the mandatory deadlines. Early adoption offers benefits such as:

• Gaining operational experience with the new identifier

• Facilitating vigilance reporting and post-market surveillance

• Ensuring internal processes are fully aligned before deadlines

Industry Impact

The introduction of the Master UDI-DI marks a significant step toward harmonisation and reduced administrative burden in UDI management. However, manufacturers should start preparing now to ensure technical readiness and regulatory compliance.

Further resources:

• MDCG 2025-7 Positionspapier (PDF)