MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

MDCG 2025-7 Rev. 1

MDCG Position Paper:

Timelines of the implementation of

‘Master UDI-DI’ to contact lenses

and spectacle frames, spectacle

lenses and ready-to-wear reading

spectacles

Revision 1-December 2025

This document has been endorsed by the Medical Device Coordination Group (MDCG)

established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European

Union can give binding interpretations of Union law.

MDCG 2025-7 Rev. 1 changes Pages 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

Background

The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices1 (‘the MDR’) aims to ensure an adequate level of identification and traceability of medical devices. Basic UDI-DIs, UDI-DIs and UDI-PIs shall be assigned (in compliance with the rules of the designated issuing entities) by manufacturers to all devices, other than custom-made devices, prior to their placement on the market. To further strengthen and enhance traceability and recording of UDIs, manufacturers shall register Basic UDI-DIs and UDI-DIs in UDI/Device registration module2 of the European Database on Medical Devices (Eudamed)3. For devices presenting a high level of individualisation (‘highly individualised devices’), notably contact lenses and spectacle frames, spectacle lenses and ready -to-wear reading spectacles, and in order to adapt the UDI-DI assignment criteria to such kind of devices, the assignment of a ‘Master UDI-DI’ has been foreseen according to Annex VI, Part C, Sections

6.6.1 and 6.6.2 of the MDR, as amended by Commission Delegated Regulation (EU)

2023/2197 on Master UDI-DI for contact lenses4 and by Commission Delegated Regulation (EU) 2025/1920 on Master UDI-DI for spectacle frames, spectacle lenses and ready -to-wear reading spectacles5. The Master UDI-DI technical solution aims to group highly individualised devices with specific similarities in terms of relevant design parameters under a common identifier to be assigned and registered in the UDI/Device registration module of Eudamed , thus relieving manufacturers, distributors and the Eudamed database from having too many identifiers assigned for similar devices. The Master UDI-DI technical solution for such devices is being developed by the EU UDI issuing entities6. According to MDCG 2021-24 Guidance on classification of medical devices7, corrective contact lenses are considered to be class IIa (short-term use) or class IIb (long-term use) medical devices. Spectacle frames (i.e. glasses) , spectacle lenses and ready -to-wear reading spectacles are considered to be class I medical devices. This MDCG Position Paper aims at clarifying the timelines of the implementation of the Master UDI-DI to the abovementioned devices, as established in the respective Delegated Regulations, and the obligation to label the Master UDI-DI and to use the UDI/Device registration module of Eudamed, and the interrelation between them.

1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1. Current consolidated version ELI: https://eur-lex.europa.eu/eli/reg/2017/745/2025-01-10). 2 https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en. 3 https://health.ec.europa.eu/medical-devices-eudamed_en. 4 Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses (OJ L, 2023/2197, 20.10.2023, ELI: http://data.europa.eu/eli/reg_del/2023/2197/oj), as amended by Commission Delegated Regulation (EU) 2025/788 of 16 April 2025 amending Delegated Regulation (EU) 2023/2197 as regards the date of application (OJ L, 2025/788, 28.7.2025, ELI: http://data.europa.eu/eli/reg_del/2025/788/oj). 5 Commission Delegated Regulation (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles (OJ L, 2025/1920, 23.9.2025, ELI: http://data.europa.eu/eli/reg_del/2025/1920/oj). 6 https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en#udi-issuing-entities.

7 https://health.ec.europa.eu/document/download/cbb19821-a517-4e13-bf87- fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf.

Reference dates

• • Application of UDI labelling requirements: As established in Article 123(3)(f) of the MDR, the provisions of Article 27(4) on the placement of UDI carriers on the label of the device and on all higher levels of packaging apply for classes IIa and IIb devices from 26 May 2023, while for class I devices they apply from 26 May 2025.
• • Mandatory use of the UDI/Device registration module in Eudamed: As established in Article 29 and in Article 123 of the MDR, as amended by Regulation (EU) 2024/18608, and 6 months after the publication on the Official Journal of the European Union (OJEU) of the notice on the functionality referred to in Article 34(3) of the MDR9, the use of the UDI/Device registration module of Eudamed becomes mandatory to use as from 28 May 2026.
• • Implementation of Master UDI-DI to contact lenses: As established in Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 , as amended, the Master UDI-DI assignment solution must be implemented by manufacturers of contact lenses as from 9 November 2026, three years after the entering into force of the act. Contact lenses produced prior to 9 November 2026 are not required to have a Master UDI-DI on the label.
• • Implementation of Master UDI-DI to spectacle frames, spectacle lenses and ready - to-wear reading spectacles: As established in Commission Delegated Regulation (EU) 2025/1920 of 12 June 2025 , the Master UDI-DI assignment solution must be implemented by manufacturers of spectacle frames, spectacle lenses and ready-to-wear reading spectacles as from 1 November 2028, approximatively three years after the entering into force of the act. The abovementioned dates are represented in the diagram below.

8 Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (OJ L, 2024/1860, 9.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1860/oj). See also “Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860” https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3- 8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf. 9 Commission Decision (EU) 2025/2371 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (OJ L, 2025/2371, 27.11.2025, ELI: http://data.europa.eu/eli/dec/2025/2371/oj).

2023 2024 2025 2026 2027 2028 2029 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4

In red the representation of the time lapses when the use of the UDI/Device registration module in Eudamed is mandatory but not the Master UDI-DI assignation solution yet:

• - for contact lenses: from the second quarter (Q2) 2026 to the fourth quarter (Q4) 2026-for spectacle frames, spectacle lenses and ready -to-wear reading spectacles: from the second quarter (Q2) 2026 to the fourth quarter (Q4) 2028

Considerations and way forward The different and partially overlapping timelines for the assignment, labelling and registration of the ‘highly individualised devices’ subject to the Master UDI-DI assignment solution (contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles) make that the obligation to label the Master UDI-DI and register those devices in the UDI/Device registration module of Eudamed follows the Master UDI-DI assignment obligation, with time laps spanning from about 5 months for contact lenses to about 29 months for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. However, the relevant Commission Delegated Regulations, in their respective Articles 2 in fine, provide for the possibility for manufacturers to voluntarily assign a Master UDI-DI before it becomes mandatory on the respective dates of application. This means that manufacturers should try to assign Master UDI-DIs as soon as possible even before the assignment becomes mandatory, with the obligation to label it and register the devices in Eudamed immediately following, after the assignment is done. From 26 May 2025 until the Master UDI-DI assignment solution (acting as UDI-DI for highly individualised devices ) is fully available through the relevant Commission Delegated Master

UDI-DI contact lenses

Master

UDI-DI spectacles

Eudamed UDI/Device registration module UDI labelling class I devices UDI labelling classes IIa and IIb devices

Regulations and the appropriate EU UDI issuing entity10 standard, the abovementioned highly individualised devices will continue to be identified with either an issuing entity identifier or similar internal manufacturer device identifier as for the current procedures.

Manufacturers of contact lenses, spectacle frames, spectacle lenses and ready -to-wear reading spectacles are strongly encouraged to make use of the voluntary assignment of Master UDI-DI before the mandatory dates of application in due time, to be able to take advantage of the features offered by the Master UDI-DI assignment solution. On the other hand, once the Vigilance and post-market surveillance module in Eudamed is mandatory to use11, Master UDI-DI, if assigned, should be used for reporting of vigilance cases for contact lenses, spectacle frames, spectacle lenses and ready -to-wear reading spectacles even though the application dates of the Commission Delegated Regulations on Master UDI-DI have not passed yet. More information on the implementation of the Master UDI-DI assignment solution for contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles is available on the guidance documents MDCG 2024-14 Rev. 112 and MDCG 2025-813, including the practical handling of reporting of vigilance cases.

10 See https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en#udi-issuing- entities.

11 Q2 2027 according to the latest available Eudamed modules timeline https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39- d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf.

12 MDCG 2024-14 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for contact lenses https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325- be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf. 13 MDCG 2025-8 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles https://health.ec.europa.eu/document/download/f026ed58-060d- 49b1-b660-914838670a20_en?filename=mdcg_2025-8_en.pdf.