Delegated Regulation 2025/1920 - UDI Assignment for Spectacle Frames and Lenses
Establishes UDI assignment requirements specifically for spectacle frames and lenses under the MDR framework. Provides clarity on unique device identification for optical devices.
📅 Effective / published: 2025
Manufacturers and sponsors placing medical devices on the the EU market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗