Unique Device Identification (UDI)
The Unique Device Identification (UDI) is a unique number designed to ensure the traceability of medical devices in the European Union. In Europe, the UDI is mandated by two key regulations: EU MDR 2017/745 and IVDR 2017/746.
Components of the UDI System
The UDI system consists of three distinct components:
- Basic UDI-DI
- UDI-DI (Device Identifier)
- UDI-PI (Production Identifier)
Basic UDI-DI
The Basic UDI-DI is specific to Europe and used primarily within the EUDAMED database for product grouping and identification. It links a family of devices under the same product group and is used for administrative purposes. Unlike the UDI-DI, it does not appear on the product or its packaging.
UDI-DI
The UDI-DI uniquely identifies a specific medical device in a manufacturer’s portfolio. It is the static portion of the UDI, assigned to the product and included on its packaging. The UDI-DI remains constant, regardless of the device’s manufacturing date, lot number, or position in a series.
UDI-PI
The UDI-PI is the dynamic part of the UDI, which changes based on production details such as lot numbers, serial numbers, or manufacturing dates.
UDI Placement and Carrier
The complete UDI, combining the UDI-DI and UDI-PI, must be displayed on the product through a UDI carrier. This carrier can take various forms, including:
- Barcodes
- Smart cards
- Biometrics
- RFID (Radio Frequency Identification)
In addition, the UDI must include a Human Readable Interpretation (HRI), which is a visible alphanumeric code. The HRI ensures accessibility in cases where automated systems, known as Automatic Identification and Data Capture (AIDC) technologies, are unavailable to read the code.
