MDCG 2025-8: New Guidance on Master UDI-DI Implementation for Spectacles and Highly Individualised Devices
The European Commission has released the MDCG 2025-8 guidance, providing detailed instructions on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. This guidance supports the application of Commission Delegated Regulation (EU) 2025/1920, which introduces specific rules for highly individualised devices (HID).
For manufacturers, this document is particularly relevant, as it clarifies:
how to assign Basic UDI-DI vs. Master UDI-DI MDCG 2025-8
triggers for when a new Master UDI-DI is required
how to apply design parameter grouping rules
expectations for labelling, packaging hierarchy, and EUDAMED registration MDCG 2025-8
vigilance reporting requirements for spectacle-related devices MDCG 2025-8
The guidance reinforces that manufacturers bear full responsibility for ensuring correct UDI assignment and maintaining traceability in line with Article 10(7) MDR and Annex VI, Part C. MDCG 2025-8
It also includes decision trees and infographics to support consistent classification and assignment across product families, promoting greater harmonisation among manufacturers.
For companies manufacturing eyewear devices or other highly individualised products, the MDCG 2025-8 provides essential clarification for market compliance, UDI strategy planning, and EUDAMED readiness ahead of the upcoming deadlines.
The full MDCG guidance can be downloaded below.
