The document MDCG 2025–7 of the Medical Device Coordination Group (MDCG) deals with the timelines for the implementation of the ‘Master UDI-DI’ system for certain medical devices such as contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
The UDI system aims to improve the identification and traceability of medical devices by assigning manufacturers a unique device identifier. For highly indivudalised products, the ‘Master UDI-DI’ has been introduced to group similar devices under a common identifier, thereby reducing the registration effort. The MDCG explains the mandatory data for UDI labelling, the mandatory use of the Eudamed UDI/device registration module and the introduction of the Master UDI-DI for the products mentioned. It also points out that manufacturers can and should assign the Master UDI-DI voluntarily before the deadlines in order to reap the benefits of the solution at an early stage.
Master UDI-DI – Challenges for Manufacturers
The main motivation for introducing the Master UDI-DI for highly customized medical devices such as contact lenses, spectacle frames, spectacle lenses and ready-made spectacles is to adapt the UDI-DI assignment criteria for this type of product. This is to avoid assigning too many identifiers to similar products. The aim is therefore to reduce the burden on manufacturers, distributors and the Eudamed database by grouping highly customized products with specific similarities under a common identifier.
A key challenge arises from the different and sometimes overlapping timelines for the assignment, labeling and registration of these highly indivudalised products. This means that the obligation to label the Master UDI-DI and register the products in the UDI/product registration module of Eudamed follows the Master UDI-DI assignment obligation, with time intervals ranging from approximately 10 months for contact lenses to approximately 30 months for spectacle frames, spectacle lenses and finished spectacle glasses.
Important timelines for UDI labelling and EUDAMED registration
The regulatory requirements relating to UDI labelling and EUDAMED modules are gradually coming into force. The most important deadlines are summarised below:
UDI labelling requirement:
- Class IIa and IIb medical devices (e.g. contact lenses): mandatory since 26 May 2023.
- Class I medical devices (e.g. spectacle frames, spectacle lenses, ready-to-wear reading spectacles): mandatory from 26 May 2025
Obligation to use the UDI/product registration module in EUDAMED:
- Will become mandatory from the first quarter of 2026 – six months after publication of the official notice in the EU Official Journal.
Master UDI-DI – mandatory introduction:
- Contact lenses: from 9 November 2026
- Spectacle frames, spectacle lenses, ready-to-wear reading spectacles: from September 2028
- (three years after the corresponding delegated regulations come into force)
- Note: Products manufactured before these deadlines do not require a Master UDI-DI on the label.
Transitional periods with EUDAMED registration requirement but without Master UDI-DI requirement:
- Contact lenses: from Q1 2026 to Q4 2026
- Spectacles: from Q1 2026 to Q3 2028
Voluntary Master UDI-DI assignment:
- Highly recommended: Manufacturers can assign Master UDI-DIs before the official deadlines.
- Important: If voluntary assignment takes place, labelling and EUDAMED registration must follow immediately.
Vigilance and post-market surveillance module:
- Mandatory from Q3 2026.
If a Master UDI-DI is available, it should already be used for reports – even if the formal obligation to assign a Master UDI-DI does not yet apply.
What needs to be done now?
The timelines are complex and overlap in some areas – the key point is that labelling and registration follow the assignment of the Master UDI-DI. Prepare early to avoid regulatory gaps. We are happy to assist you.
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