Introduction and scope
The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR) aims to ensure an adequate level of identification and traceability with respect to medical devices. Basic UDI-DIs, UDI-DIs and UDIPIs 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 the European Database on Medical Devices (Eudamed).
For contact lenses, which are devices presenting a high level of individualisation (‘highly individualised devices’), the assignment of a Master UDI-DI has been foreseen according to Annex VI, Part C, Section 6.6.1 MDR, as amended by Commission Delegated Regulation (EU) 2023/2197 on Master UDI-DI for contact lenses.
Even though all economic operators have to contribute to an appropriate level of traceability according to Article 25 MDR, the main responsibility to apply the means to achieve proper identification and traceability of the device lies with the manufacturer.
This document aims to provide guidance in the implementation of Master UDI-DI rules for contact lenses as regards its structure, assignment, labelling and registration in Eudamed.
NOTE: this document is intended to be read in conjunction with Regulation (EU) 2017/745 on medical devices (MDR), Commission Delegated Regulation (EU) 2023/2197 and other MDCG Guidance documents on UDI.
MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)
MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)
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