Unit of Use DI

The Unit of Use DI (UoU DI) is an identifier (following the UDI rules of the chosen issuing entity) assigned to an individual medical device when a UDI is not labelled on the individual device at the level of its unit of use. Its purpose is to provide a UDI-DI to identify a device used on a patient when a UDI-DI does not appear on the label of the device.

For example: If the lowest base packaging level with a identified UDI, has a device count greater than 1, a Unit of Use DI (UoU DI) shall be assigned.

If the device is not directly marked and the base quantity of the device is greater than one, the Unit of Use DI shall be provided within EUDAMED.

The Issuing entity for the Unit of Use DI Code is the same as the UDI-DI.

According to Annex VI, Part C, Section 1, the Unit of Use-DI is defined as follows:

"The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not placed on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together."

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424

Please refer for further details to:

“Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices” (May 2021; MDCG 2021-10)

https://ec.europa.eu/health/system/files/2021-06/md_2021-10_en_0.pdf