Unique Device Identification (UDI) is a global identification system designed to enhance the traceability and security of Medical Devices and in vitro diagnostic Medical Devices. The UDI consists of a series of alphanumeric codes that enable the unique identification of each device, facilitating monitoring throughout the supply chain.
The UDI code consists of two distinct parts:
- UDI-DI (Device Identifier)
The UDI-DI is the unique identifier assigned to a specific device model.
This identifier remains unchanged for all devices sharing the same model, configuration and intended use. Any significant change to the device, such as a change in size, type or packaging, requires the assignment of a new UDI-DI.
- UDI-PI (Production Identifier)
The UDI-PI is the identifier for the individual production unit of a device.
It includes, where appropriate, the following elements:
- Lot or serial number
- Software identifier (if applicable)
- Date of manufacture
- Expiry date
The UDI-PI varies for each piece and each production batch.
Key features of the UDI
- Dual format: the UDI appears on the device label either in human-readable format or in AIDC (Automatic Identification and Data Capture) format, e.g. a linear barcode or a 2D code (e.g. a Data Matrix).
- Scannability: it is designed to be easily read and scanned by healthcare professionals, distributors and regulatory authorities.
- Registration in EUDAMED: the UDI-DI must be registered in the European database EUDAMED. This registration associates the UDI-DI with key information on the device.
