The UDI or Unique Device Identification is a unique number used to provide the traceability of a medical device in the European Union and the USA. In Europe the UDI is a requirement of the two medical products regulations: EU MDR 2017/745 and IVDR 2017/746.

The concept of the UDI comprises three identification numbers:

• Basic UDI-DI
• UDI-DI (Device Identifier)
• UDI-PI (Production Identifier)

The Basic UDI-DI is used only in Europe for product identification within the EUDAMED database. It identifies a group of products, and it is different from the UDI-DI. It is a code used for administrative purposes to identify the manufacturer and to group devices that are part of the same product family.

UDI: Unique Device Identification - infographic (PDF)

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The UDI-DI identifies a specific device on a manufacturer’s portfolio. It is placed on the medical device’s packaging as the static part of the UDI number. The same product has always the same UDI-DI regardless of the manufacturing date, lot number or its position in a series.

The UDI-PI is the dynamic part of the UDI that varies from series to series and from lot to lot.

The entire UDI (UDI-DI and UDI-PI) should be placed on the product through the UDI-carrier. The UDI can appear on the packaging in different forms e.g. a barcode, smart cards, biometrics and RFID (Radio Frequency Identification). But a legible part should also be available. Which makes two parts of the UDI:

• Automatic Identification and Data Capture (AIDC) - a technology used to automatically capture data. 
• Human Readable Interpretation (HRI), which is a legible code comprised of numbers and letters and placed on the UDI carrier. This part of the code may come in handy in case there is no automatic system to read the code.