The Medical Device Coordination Group (MDCG) has just published Position Paper MDCG 2025-7 on Master UDI-DI implementation timelines for:
- Contact lenses
- Spectacle frames, corrective lenses
- Ready-to-use reading glasses
Key dates to remember:
- UDI on labelling of Class I devices: from May 26, 2025
- Mandatory UDI registration in EUDAMED: Q1 2026
- Mandatory implementation of Master UDI-DI:
→ Contact lenses: from November 9, 2026
→ Frames & lenses: from September 2028
Manufacturers may, however, voluntarily anticipate the award of Master UDI-DI to benefit earlier from its advantages in terms of traceability, inventory management, and post-market vigilance.
A further step towards improved traceability, safety, and transparency of optical medical devices in Europe.
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