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 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 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…
