UDI (Unique Device Identification) is a system designed to enable the identification and facilitate the traceability of medical devices. It consists of two parts: the UDI-DI, which is specific to a manufacturer and a device, and the UDI-PI, the variable part which can include information such as lot number, serial number, expiration date or manufacturing date. UDI is crucial because it formally identifies specific devices on the market, helps improve safety and post-market surveillance, helps reduce medical errors, and facilitates product recalls by quickly identifying affected devices.

The Basic UDI-DI is an identifier that covers a group of products sharing the same purpose, the same essential design and manufacturing characteristics, the same risk class, the same legal manufacturer and the same notified body (if applicable). It serves as the primary key in EUDAMED and is used in regulatory documentation (certificates, declarations of conformity, technical documentation). The Basic UDI-DI is never printed on the product or its label. UDI-DI, on the other hand, uniquely identifies a medical device. It is the UDI-DI (accompanied by the UDI-PI) which is found on the product label in the form of a barcode and clear text. A Basic UDI-DI can be linked to several UDI-DIs, but a UDI-DI is linked to only one Basic UDI-DI.

Yes, you must assign a Unique Device Identifier (UDI) to each of your devices, unless it is a custom device. UDI is essential for identification and traceability. The UDI is made up of two parts: the UDI-ID (Basic Device Identifier) ​​which is specific to the device model and manufacturer, and the UDI-PI (Production Identifier) ​​which contains variable information such as batch or serial number. “UDI media” (such as a barcode and human-readable form) must be affixed to the device label and all higher levels of packaging (boxes, etc.), but not to shipping containers. For reusable devices, UDI support must also be on the device itself. The "Basic UDI-DI" (part of the UDI) is the master key to link the device information into the EUDAMED database. “Basic UDI-DI” never appears on the labeling.

The UDI must be displayed on the device label or on the device itself, and on all higher packaging levels. Shipping containers are excluded from higher packaging levels. For reusable devices, the UDI must also be affixed to the device itself. In case of limited space on the packaging of the unit of use, the UDI support can be affixed to the immediate higher packaging level. For Class I and IIa single-use devices packaged and labeled separately, the UDI may not appear on the unit packaging but on a higher level of packaging (such as a cardboard box containing several individually packaged devices), unless the user does not have access to that level of packaging (for example, in the case of home care).

Yes, this is completely normal. Basic UDI-DI should never appear on device labeling. Its function is regulatory and is used as the master key in EUDAMED and in documents such as CE certificates and EU declarations of conformity.