Expansion
How should the UDI appear on the labeling or packaging of the device?
The UDI carrier should be on the label or on the device itself, as well as on all higher levels of the device's packaging, or on a higher level of packaging if space is limited in the device's unit packaging.
The higher level packaging shall have its own separate UDI, noting that shipping containers are not subject to this requirement. The UDI must be in the form of a text-only version/human-readable information (HRI) as well as in the form of AIDC technology, which refers to any technology that conveys a unique device identifier or a device identifier for a device in a form that can be entered into the electronic medical record or other computerized system through an automated process. HRI consists of clear characters that are easy to read.
If a situation exists that restricts the use of both AIDC and HRI on a label, only the AIDC format is required to appear on the label. However, for devices intended for use outside of a healthcare facility (e.g., home care devices), HRI is required even if there is no space on the label for AIDC to be placed on the label.For individually packaged and labeled Class I and Class IIa single-use medical devices, as well as Class A and Class B single-use IVD devices, the UDI carrier is not required to be present on the product packaging, but rather on the higher level packaging, such as a carton containing several (individually wrapped) devices. However, in cases where the higher level device packaging is not accessible to the healthcare provider (e.g., in a home healthcare setting), the UDI should be placed on the packaging (of individual devices).
For devices intended exclusively for use at the retail point of sale, the UDI-PI in the AIDC is not required to appear on the point-of-sale package. If the UDI carrier is easy to read, e.g. by scanning the packaging of the device if an AIDC is available, it is not necessary to print the UDI carrier on the packaging.