UDI assignment for Spectacle lenses & Ready readers

The MDR is introducing the obligation of manufactures to assign the Unique Device Identification  (UDI) on their devices, in order to improve the identification of devices and enhance the effectiveness of post-market surveillance activities.

However, sometimes the assignment of the UDI to a device and, if applicable, to all higher levels of packaging in accordance with the MDR Article 27 is not that evident on specific devices.

Taking into account the nature of Spectacle lenses and Ready readers and for the purpose of adding data to EUDAMED, the MDCG published a new Position Paper on the Basic-UDI-DI and UDI-DI groupings (Annexes I and II below), which are outlining BASIC-UDI level, UDI-DI level and UDI-PI level for both types of the device.

Source of images: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_18_en.pdf

N.B. This MDCG guidance should be read in conjunction with the MDR (notably Chapter III and Annex VI) and UDI guidance documents.

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