UDI-DI carrier updates: May 2025 changes
From May 2025 (or when the manufacturing date is from May 2025), all medical device manufacturers, including Class I, will be required to include the UDI carrier or the UDI-DI on their label, provided that the products are already regulated under the MDR or Regulation (EU) 2017/745 governing medical devices.
The UDI-DI on the label is the alphanumeric code that helps improve the traceability of the medical device.
The UDI-DI is also known as GTIN13 and is the standard code used internationally to identify trade item units intended for retail points of sale or the final consumer. However, it may also be known as GTIN14 because, in that case, it includes one additional digit, and it identifies groupings of medical devices of the same unit; therefore, it is usually placed on the box labelling, identifying the box or packaging that contains the same medical device.
The DI part of the UDI carrier is static, as it does not change except in cases such as changes to the product name, for example; however, the PI part must always change with each production unit.
We recommend that everyone involved in the marketing, manufacture, and distribution of medical devices begin to become gradually familiar with the UDI code, since it is the responsibility of all actors involved in the medical device marketing process to ensure that the UDI code is implemented on the labelling and to verify that it complies with the guidelines for its coding. With the UDI code becoming mandatory imminently for all types of medical devices, it is essential that an actor is properly advised on its review and implementation; and, of course, at Medical Devices Sur Consulting we can advise you with complete confidence on its correct implementation for medical devices.