MDCG Issues Master UDI-DI EU Guidance for Contact Lenses 

Today, the EU published an updated revision of the Medical Device Coordination Group (MDCG) Guidance document MDCG 2024-14, which provides revised guidance on implementing the Master UDI-DI solution for contact lenses. 

This revision reflects regulatory changes and clarifications that are highly relevant for manufacturers preparing for upcoming UDI and EUDAMED requirements. 

For more information about MedEnvoy’s EUDAMED service, click here.

What Has Changed in this Revision? 

The main updates compared to the 2024 guidance are: 

1. Updated Legal References 

• Added reference to Commission Delegated Regulation (EU) 2025/788, which amends the date of application of the Master UDI-DI requirement. 

• Updated link to the current consolidated version of the MDR. 

2. Extended Transition Period 

• Under the original Delegated Regulation (EU) 2023/2197, the Master UDI-DI requirement applied from 9 November 2025. 

• Revision 1, following Regulation (EU) 2025/788, extends the date of application to 9 November 2026, giving manufacturers an additional year to comply. 

• This effectively provides a three-year transition period from the entry into force (9 November 2023). 

3. New References for Clarity 

• Added references to the MDCG 2025-7 Position Paper on Master UDI-DI timelines. 

• Included a link to the Commission’s webpage on “Master UDI-DI for highly individualised devices”, providing broader context beyond contact lenses. 

What Remains the Same? 

The core UDI-DI EU guidance remains unchanged, including: 

• Terminology and definitions (Standard vs Made-to-Order contact lenses, Basic UDI-DI, Master UDI-DI, UDI-PI). 

• Assignment rules for standard and made-to-order lenses. 

• Labelling requirements, including examples of how Master UDI-DI identifiers should appear. 

• Packaging levels and grouping rules for container packages. 

• Vigilance reporting obligations, including reporting for both MDR-compliant and legacy contact lenses. 

• EUDAMED registration process, where Master UDI-DI replaces the UDI-DI for contact lenses. 

Updated EU UDI-DI Timeline 

Why This Matters 

• The extension provides more preparation time for manufacturers, especially those managing large product portfolios or complex EUDAMED registrations. 

• It also aligns timelines with broader MDCG considerations for highly individualised devices (HID), including spectacle frames, lenses, and reading spectacles. 

• Manufacturers should still engage early with issuing entities and prepare their data structures in EUDAMED to avoid bottlenecks before the new 2026 deadline. 

How MedEnvoy Can Support 

At MedEnvoy, we understand the complexity of Master UDI-DI implementation and the challenges manufacturers face in navigating both regulatory and technical requirements. We can support by: 

• EUDAMED Registration Management – ensuring timely and accurate registration of Basic UDI-DIs and Master UDI-DIs in the UDI/Devices module. 

• Master UDI-DI Strategy – advising on how to structure Master UDI-DIs for standard and made-to-order lenses, aligned with Annex VI and the MDCG guidance. 

• Data Governance & Labeling – helping design compliant labelling solutions (AIDC, HRI, blister packs, packaging levels). 

• Vigilance & PMS Integration – ensuring UDI traceability links correctly into your PMS, vigilance, and QMS systems. 

• Regulatory Intelligence – keeping you updated on evolving guidance, such as MDCG 2025-7 and future Commission updates. 

MedEnvoy offers expert regulatory support to manufacturers in navigating UDI-DI implementation requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.