Master UDI-DI in EUDAMED:
which products manufacturers must register now – and which ones not yet
Executive Summary
- contact lenses from 9 November 2026,
- spectacle products from 1 November 2028.
However, this special rule does not postpone the registration obligation for all other products.
1. Why is there uncertainty at the moment?
The uncertainty arises from two parallel developments: on the one hand, the first four EUDAMED modules have become mandatory. On the other hand, the technical and regulatory Master UDI logic for certain highly individualised products is being introduced at a later stage.
Many manufacturers therefore ask a legitimate question: do I have to register products in EUDAMED now, even though the Master UDI-DI for my product group will only apply later? The technically correct answer is: it depends on the product type.
Key message: The Master UDI-DI is not a general postponement of EUDAMED obligations. It is a special logic for certain highly individualised MDR products. Standard MDR/IVDR products remain unaffected by this special logic.
2. General EUDAMED obligation since 28 May 2026
The European Commission confirms that, since 28 May 2026, four EUDAMED modules must be used: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates and Market Surveillance. The Commission refers to Commission Decision (EU) 2025/2371, which was published in the Official Journal of the European Union on 27 November 2025 and triggered the six-month transitional period.
The UDI/Device module is therefore central to device registration. Manufacturers must submit the UDI/device information for the products they place on the EU market. For products under the MDR and IVDR, registration generally takes place at Device Identifier level, in particular at UDI-DI level; production identifiers such as lot numbers or serial numbers are not registered as separate product registrations for each individual unit.
New products from 28 May 2026 onwards
If the first saleable unit of a Regulation Device or System/Procedure Pack with a specific UDI-DI is placed on the EU market on or after 28 May 2026, registration in the UDI/Device module must have been completed before this first placing on the market.
Products already placed on the market before 28 May 2026
If the first unit of a Legacy Device or Regulation Device was already placed on the market before 28 May 2026 and further units with the same UDI-DI continue to be placed on the market on or after the mandatory date, a retrospective registration period applies. According to the EU transition overview, this period ends on 28 November 2026.
Practical rule: Manufacturers of standard MDR/IVDR products should not wait for the Master UDI-DI. The obligation to register UDI/device data is already active.
3. What is the Master UDI-DI?
The Master UDI-DI was introduced for products with a high degree of individualisation. For such products, a very large number of variants may exist, although they are highly comparable from a regulatory and technical perspective. A normal UDI-DI for every variant would result in a very large number of data records.
The Master UDI-DI is intended to group comparable product variants under one common identifier based on defined parameters. For the affected product groups, it functions in EUDAMED as a special form of Device Identifier.
The Master UDI-DI currently applies in particular to the following MDR product groups:
- Standard soft contact lenses
- Standard rigid gas permeable contact lenses
- Made-to-order soft contact lenses
- Made-to-order rigid gas permeable contact lenses
- Spectacle frames
- Spectacle lenses
- Ready-made reading spectacles
Important: Based on the current status, the Master UDI-DI concerns MDR products. No comparable Master UDI special logic for IVD products is described on the official Commission pages. IVD manufacturers should therefore generally assume that the standard UDI/Device Registration logic under the IVDR applies.
4. Which deadlines apply?
| Product / case group | EUDAMED registration | Relevant date | Practical assessment |
|---|---|---|---|
| Standard MDR/IVDR products first placing on the market from 28 May 2026 onwards |
Mandatory | Before first placing on the market | UDI/Device Registration must be completed before market entry. |
| Legacy or Regulation Devices first unit before 28 May 2026, further units afterwards |
Mandatory | By 28 November 2026 at the latest | Systematically review the backlog and complete retrospective registration in time. |
| Contact lenses | Special logic | Master UDI-DI from 9 November 2026 | Registration follows the Master UDI obligation. Preparation is required now; voluntary earlier assignment is possible. |
| Spectacle frames, spectacle lenses, ready-made reading spectacles | Special logic | Master UDI-DI from 1 November 2028 | Do not force normal UDI-DI registration at this stage. EUDAMED currently blocks these Special Device Types at system level. |
| Products no longer placed on the market after the mandatory date | Generally no registration | Only relevant in case of a PMS/vigilance action | No registration in the UDI/Device module is required unless a PMSV action is triggered. |
| Custom-made devices | Not in the UDI/Device module | Only a limited data set in case of vigilance needs | Do not treat as normal UDI/Device Registration. |
5. Contact lenses: Master UDI-DI from 9 November 2026
For contact lenses, the Master UDI-DI was introduced by Delegated Regulation (EU) 2023/2197; its application was postponed to 9 November 2026 by Delegated Regulation (EU) 2025/788. MDCG Position Paper 2025-7 Rev. 1 confirms that Master UDI assignment for contact lenses must be implemented from that date.
The decisive point is the MDCG position on the interaction with EUDAMED: for the affected highly individualised products, the obligation to mark products with a Master UDI-DI and to register them in the UDI/Device module follows the respective Master UDI assignment obligation. According to this position, contact lenses produced before 9 November 2026 do not necessarily have to carry a Master UDI-DI on the label.
At the same time, manufacturers are encouraged to make use of voluntary earlier assignment of the Master UDI-DI as soon as this is practically possible. If a Master UDI-DI is assigned voluntarily, labelling and EUDAMED registration should follow accordingly.
Recommendation for contact lens manufacturers: Do not wait until the deadline is reached. Grouping logic, parameter ranges, UDI issuing entity, labelling impact, EUDAMED data model and QMS documentation should be prepared now.
6. Spectacle products: Master UDI-DI from 1 November 2028
For spectacle frames, spectacle lenses and ready-made reading spectacles, Delegated Regulation (EU) 2025/1920 provides for a later implementation. Master UDI assignment is expected to become mandatory for these product groups from 1 November 2028.
There is also an important technical point: the EUDAMED Information Centre states that certain Special Device Types currently cannot be registered. If Spectacle frames, Spectacle lenses or Ready-made reading spectacles are selected, the system blocks saving the record. Registration via Machine-to-Machine or Bulk Upload is also not possible.
Recommendation for manufacturers of spectacle products: Do not attempt substitute registrations using an incorrect product logic. Instead, prepare the Master UDI data model, product parameters, ERP/PLM structure, Basic UDI grouping and QMS traceability, and monitor system enablement by the Commission.
7. Timeline
- 27 November 2025:
Publication of Commission Decision (EU) 2025/2371 in the Official Journal. This establishes the functional status of the first four EUDAMED modules and triggers the six-month transitional period.
- 28 May 2026:
Actor Registration, UDI/Device Registration, Notified Bodies & Certificates and Market Surveillance become mandatory.
- 9 November 2026:
Master UDI-DI for contact lenses becomes mandatory.
- 28 November 2026:
Deadline for registering certain Legacy and Regulation Devices that were already placed on the market before the mandatory date and continue to be marketed afterwards.
- 1 November 2028:
Master UDI-DI for spectacle frames, spectacle lenses and ready-made reading spectacles becomes mandatory.
8. What manufacturers should do now
1. Segment the portfolio clearly
The most important immediate action is a clear segmentation of the portfolio. Standard MDR/IVDR products, contact lenses, spectacle products, Legacy Devices, custom-made devices and products no longer placed on the market must not be treated according to the same logic.
2. Prioritise the UDI/Device backlog
For standard MDR/IVDR products, the UDI/Device backlog should be reviewed immediately. Particularly relevant data points include Basic UDI-DI, UDI-DI, EMDN code, risk class, trade name, model/catalogue numbers, certificate references, manufacturer data and, where applicable, Authorized Representative or importer.
3. Prepare the Master UDI data model
Manufacturers of contact lenses and spectacle products should not start building the Master UDI logic shortly before the deadline. Clear grouping rules, defined parameter ranges, alignment with the UDI issuing entity, ERP/PLM adaptations and internal responsibilities for data release and data quality are required.
4. Avoid incorrect substitute registrations
Particular caution is required for spectacle products. If EUDAMED blocks certain Special Device Types at system level, manufacturers should not attempt to force registration through unsuitable substitute categories. This may later lead to data inconsistencies and correction effort.
5. Ensure QMS and audit readiness
EUDAMED data is not merely IT data. It must be consistent with technical documentation, Declaration of Conformity, labelling, certificates and internal master data. Discrepancies between regulatory documentation and the EUDAMED data record may become problematic in audits and certification processes.
9. Conclusion
The situation is differentiated, but not arbitrary. Since 28 May 2026, the EUDAMED obligation applies to the first four modules. Manufacturers of standard MDR/IVDR products must generally register their products now: new products before first placing on the market, and certain products already placed on the market before the mandatory date by 28 November 2026 at the latest.
The Master UDI-DI does not postpone this general obligation. However, it creates a special logic for certain highly individualised MDR products. Contact lenses follow the Master UDI obligation from 9 November 2026. Spectacle frames, spectacle lenses and ready-made reading spectacles follow from 1 November 2028; in addition, their registration in EUDAMED is currently blocked at system level.
Manufacturers should therefore not ask in general terms whether EUDAMED “already applies” or “does not yet apply”. The correct question is: Which product group is involved, which UDI logic applies, and which deadline is relevant for this specific product group?
Sources and further reading
- European Commission: EUDAMED Overview
- European Commission: EUDAMED UDI/Device Registration
- European Commission / MDCG: Q&A on the gradual roll-out of EUDAMED pursuant to Regulation (EU) 2024/1860
- European Commission: EUDAMED registration of devices – transition period
- MDCG 2025-7 Rev. 1: Timelines of the implementation of Master UDI-DI to contact lenses and spectacle products
- EUDAMED Information Centre: Basic UDI-DI information – Special Device Types
- EUR-Lex: Commission Decision (EU) 2025/2371
- EUR-Lex: Regulation (EU) 2024/1860
This technical article is based on publicly available regulatory information as of 17 June 2026. MDCG documents and Q&A documents provide practical interpretation and guidance; binding interpretation of Union law remains reserved to the competent courts. This article does not replace individual legal or regulatory advice.
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