EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
In April 2017, the European Parliament and the Council adopted Regulations (EU) 2017/745 on medical devices (MDR) 1 , 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 MDR, aiming to ensure an adequate level of traceability with respect to medical devices and in vitro diagnostic medical devices. Basic UDI-DIs, UDI-DIs and 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 the 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 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 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 clinical parameter combinations cause a level of granularity not needed for regulatory purposes.
A current example of highly individualised devices concerned is contact lenses, which has been the focus of the discussions both at EU and international level.
Other jurisdictions that implement a UDI system are faced with the same implementation problem with respect to contact lenses but have the possibility to grant an exemption to manufacturers of those highly individualised devices, to not report the UDI-DIs entries in their UDI Databases.
The MDR does not provide for the possibility to grant such an exemption in the EU. Therefore, in order to resolve the implementation issue and allow for proportionate UDI-DI data entries in Eudamed, the “Master UDI-DI” has been developed by the Commission in close collaboration with regulators and relevant stakeholders, including industry, contact lenses experts and EU issuing entities. Master UDI-DI is intended as the identifier of a group of highly individualised devices (i. e. contact lenses) presenting specific similarities with respect to defined clinically relevant parameters. Whilst in the future the Master UDI-DI solution could be extended to other highly individualised devices, at present the focus remains on contact lenses. Should the need arise, the Commission will propose a new delegated act to extend the Master UDI-DI solution to other devices.
The concept of a UDI-DI grouping several devices is already present in the MDR, with respect to system and procedure packs, configurable devices and software 5 . Therefore, the Commission proposes, through a delegated act to be adopted pursuant to Article 27 (10) (b) MDR, an amendment to Part C of Annex VI to Regulation (EU) 2017/745, adding a section concerning ‘highly individualised devices’ and specifically contact lenses, in order to adapt the UDI-DI assignment criteria to such kind of devices and introducing 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). 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) 6 , 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 contact lenses, a number of meetings with relevant stakeholders took place (2019-2022), in particular with relevant associations for eyewear products including contact lenses, spectacle frames and ready readers.
Moreover, meetings with the EU UDI issuing entities on the subject matter took place during the course of 2019-2022 in order to analyse, identify and develop possible new solutions to enable technical progress in the field of Unique Device identification.
The EU also discussed the identified issues for UDI implementation with global partners and other international Regulators.
In the MDCG UDI subgroup, a series of workshops with regulators and stakeholders took place in 2020. 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” solution.
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.
This draft Delegated Regulation has also undergone the 4-week public feedback period under the Better Regulation framework. The feedback received mainly focused on the proposal for clinical sizes to be included as additional production identifiers of contact lenses (UDI-PI) for which concerns were raised as regards the enlargement of the barcodes and the fact that the potential benefit did not outweigh the burden of implementation. The feedback received has been reflected in this Delegated Regulation by removing the provision on clinical sizes to be included as additional production identifiers of contact lenses.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
The proposed Regulation is a Delegated measure adopted pursuant to Article 27 (10) (b) of Regulation (EU) 2017/745 whereby the Commission is empowered to amend Annex VI of that Regulation 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 contact lenses, 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.