Adoption of Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application and new revision of MDCG 2024-14
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Adoption of Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application and new revision of MDCG 2024-14
Regulatory Affairs Medical Devices
Tuesday, 30 September 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 28 July 2025the Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application was adopted.
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Adoption of Commission Delegated Regulation (EU) 2025/788 | QbD Group
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The amendment defers the application of the rules on the assignment of Unique Device Identifiers (UDI) for contact lenses as highly individualised devices, introduced through the Master UDI-DI solution, to 9 November 2026. The change responds to the need for operators to have sufficient time to implement the technical and organisational requirements, following the publication of the MDCG 2024-14 guidance on the implementation of the Master UDI-DI solution for contact lenses. By postponing the application date, the amendment ensures greater legal certainty, allows adequate planning and resource allocation, and supports a smoother transition to the new UDI framework.
On 26 August 2025, the Medical Device Coordination Group (MDCG) released a new revision of the MDCG 2024-14 which includes guidance on the implementation of the Master UDI-DI solution for contact lenses. The revision of the MDCG includes references to the Delegated Regulation 2025/788 and the new date of application of the Master UDI-DI for contact lenses (9 November 2026).
What does this mean for you?
Manufacturers now have extended time to implement the Master UDI-DI for contact lenses, allowing for better resource allocation, planning, and system adaptation. Ensure your UDI and EUDAMED processes are aligned with the updated timelines.
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