---
title: "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"
description: "On 28 July 2025, the Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 regarding its application date was adopted. The amendment defers the application of the rules on Unique Device Identifiers (UDI) for contact lenses to 9 November 2026, ensuring manufacturers have sufficient time to implement the required technical and organizational changes."
url: https://qbdgroup.com/zh-cn/regulatory-updates/adoption-of-commission-delegated-regulation-2025-788
type: "Regulatory update"
language: zh-cn
published: 2025-09-30
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"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\", https://qbdgroup.com/zh-cn/regulatory-updates/adoption-of-commission-delegated-regulation-2025-788"
---
# 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
> On 28 July 2025, the Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 regarding its application date was adopted. The amendment defers the application of the rules on Unique Device Identifiers (UDI) for contact lenses to 9 November 2026, ensuring manufacturers have sufficient time to implement the required technical and organizational changes.

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](https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf) 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.

[![CTA RA update MD](https://no-cache.hubspot.com/cta/default/7030766/interactive-185449024004.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLJ0NjTAqupFElCCoQeLe7%2F3TdBetO41QGXHA9ebhWCfoXiMIhpcE5%2FvFe7Mq8j74EjCvRYHut%2BWRrZE1SogEwvb9zZ5VXRXxy0Yn01hYLPjlxJ8hNlfML5sg446Ea18f5G%2BHd5e5Hqyc1U5fmBHQg9Zt6%2BnIhWnHxfe9ie4ecWxRXqj%2B0JAMxowKjDjvreFseFcWg3rcNOOForRijMVxKXNig%3D%3D&webInteractiveContentId=185449024004&portalId=7030766)
---
Source: https://qbdgroup.com/zh-cn/regulatory-updates/adoption-of-commission-delegated-regulation-2025-788 — © QbD Group. Quote freely with attribution and a link back.