EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
In April 2017, the European Parliament and the Council adopted Regulation (EU) 2017/745 on medical devices 1 (‘the MDR’) aiming to introduce a new robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures a high level of safety, health and innovation.
One of the main changes from the previous Directives 2 is the introduction of the Unique Device Identification (‘UDI’) system referred to in Article 27 of the MDR, aiming to ensure an adequate level of traceability with respect to medical devices. Basic UDI device identifiers (‘UDI-DIs’), UDI-DIs and UDI production identifier (‘UDI-PIs’) shall be assigned (in compliance with the rules of the designated EU issuing entities 3 ) 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 report Basic UDI-DIs and UDI-DIs in the European Database on Medical Devices (‘Eudamed’) 4 .
UDI-DI is defined in Part C of Annex VI to the MDR as the identifier specific to a manufacturer and a device. Experience gained through the setting up and implementation of the UDI system in the EU and in other jurisdictions internationally shows that certain devices present a high level of individualisation (‘highly individualised devices’), resulting in a disproportionate level of granularity and amount of UDI-DIs which would need to be reported in UDI databases e.g. Eudamed in the EU. In comparison with other medical devices, the numerous possible design (clinical and non-clinical) parameter combinations cause an extremely high level of granularity not really needed for regulatory purposes.
Current examples of highly individualised devices are contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles 5 .
Therefore, in order to resolve the implementation issue and allow for proportionate UDI-DI data entries in Eudamed, the concept of ‘Master UDI-DI’ has been developed by the Commission in close collaboration with regulators and relevant stakeholders, including industry, product experts and EU issuing entities. Master UDI-DI is intended as the identifier of a group of highly individualised devices (i.e. contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles) presenting specific similarities with respect to defined design (clinically and non-clinically) relevant parameters.
The concept of a UDI-DI grouping several devices is already present in the MDR, with respect to systems and procedure packs, configurable devices and device software 6 . The Master UDI-DI concept was introduced in the MDR for contact lenses by Commission Delegated Regulation (EU) 2023/2197 7 , adding, in Section 6 of Part C of Annex VI to the MDR, a new Section 6.6. on ‘Highly individualised services’ and a Subsection 6.6.1. on ‘Contact lenses’.
As announced in the Explanatory Memorandum of the Commission Proposal for that act for contact lenses, the Master UDI-DI concept could be extended to other highly individualised devices: this is now the case of spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Should the need arise, the Commission will propose new delegated acts to further extend the Master UDI-DI concept to other devices.
Therefore, the Commission proposes, through a delegated act to be adopted pursuant to Article 27(10)(b) of the MDR, a new amendment to Section 6 of Part C of Annex VI to the MDR, adding a Subsection 6.6.2. on ‘Spectacle frames, spectacle lenses and ready-to-wear reading spectacles’, in order to adapt the UDI-DI assignment criteria to such kind of devices, within the Master UDI-DI concept.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
Implementation of the UDI system by industry in the EU began in 2012 on a voluntary basis, jointly with other international regulators at the level of the International Medical Device Regulators Forum (IMDRF) 8 . The IMDRF UDI Working Group (WG) was chaired by the EU. Following the adoption of the MDR, the Commission UDI expert group was established in 2019, which is a subgroup of the Medical Devices Coordination Group (MDCG) 9 , although its predecessor under the Directives was also active prior to that time.
In order to discuss the implementation issue with regards to assignment of UDI-DIs to spectacle frames, spectacle lenses and ready-to-wear reading spectacles, following the work already carried out on contact lenses, a number of meetings with relevant stakeholders took place (2022-2024), including with relevant business associations for eyewear products including contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
In the MDCG UDI Subgroup (Working Group 9), which includes representatives of competent authorities of the Member States and of organisations of economic operators, patients and users of medical devices, a series of workshops and other consultations, communication and exchange activities on the Master UDI-DI concept with regulators and stakeholders took place since 2020. Views, opinions and proposals from stakeholders were analysed by regulators and the Commission, and in 2021 the MDCG UDI Subgroup agreed to proceed with the implementation of the Master UDI-DI concept for different types of devices, starting with contact lenses. Following the agreement reached at the level of the MDCG UDI Subgroup, the Commission submitted a request to the EU issuing entities in order to start the work for the implementation of the proposed solution. In the MDCG UDI Subgroup meeting held in November 2023, it was decided to extend the Master UDI-DI concept also to spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
In a similar way as done for the preparation of the delegated act on contact lenses, this draft Delegated Regulation on spectacle frames, spectacle lenses and ready-to-wear reading spectacles is going to be open for feedback during 4 weeks on the “Have Your Say” platform https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14414-Medical-devices-spectacle-frames-lenses-and-ready-made-reading-glasses-unique-identifiers-_en.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
The proposed Regulation is a Delegated measure adopted pursuant to Article 27(10)(b) of the MDR whereby the Commission is empowered to amend Annex VI to the MDR in light of international developments and technical progress in the field of Unique Device Identification. In order to resolve the implementation issue concerning the registration of UDI-DI data elements in Eudamed for spectacle frames, the Commission is empowered to establish a specific UDI-DI assignment rule for such devices. This solution will allow for a more effective implementation of the UDI system at Union level for spectacle frames, spectacle lenses and ready-to-wear reading spectacles as already done with contact lenses.
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