The MDCG has recently updated a guidance document concerning the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this document, the Unique Device Identification (UDI) system under Article 27 MDR ensures the traceability of medical devices by requiring manufacturers to assign and register UDI identifiers in the EUDAMED database. For highly individualised devices, such as contact lenses, spectacle frames, lenses, and ready-to-wear reading glasses, a Master UDI-DI system has been introduced. This allows similar devices to be grouped under a single identifier, reducing administrative burden for manufacturers, distributors, and EUDAMED. The MDCG clarifies the timelines for implementing the Master UDI-DI, the obligations for labelling these devices, and their registration in EUDAMED, while also providing classification guidance: corrective contact lenses are class IIa/IIb, whereas spectacle frames, lenses, and ready-to-wear reading spectacles are class I.
Most notably, the updated guidance includes a revised timeline that clearly outlines the implementation dates aligned with the published EUDMAED timelines, as shown below.
The full list of updates to the guidance document can be seen below:
- Page 3,4: Insertion of references to Commission Delegated Regulation (EU) 2025/788 and to Commission Delegated Regulation (EU) 2025/1920
- Page 4: Insertions of reference to the notice on functionality and of the date of mandatory use as of 28 May 2026, and removal of the reference to the “latest available EUDAMED timeline”
- Page 4: Update of the date of applicability of Commission Delegated Regulation (EU) 2025/1920
- Page 5: Update of the diagram representing the reference dates and the time lapses
- Page 6: Update of the possible date of mandatory use of the Vigilance and post-market surveillance module in EUDAMED
- Page 6: Insertion of references to guidance documents MDCG 2024-14 Rev. 1 and MDCG 2025-8
The updated guidance can be accessed using the following link
