MDCG 2025-8: New Guidance on Master UDI-DI Implementation for Spectacles and Highly Individualised Devices

The new MDCG 2025-8 guidance provides detailed rules for manufacturers on how to implement the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Covering UDI assignment, design parameter grouping, EUDAMED registration and vigilance obligations, this document is essential for manufacturers of highly individualised devices seeking MDR compliance and improved traceability.