About the unique device identifier

"The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components

• a unique device identifier (Device Identifier – UDI-DI)
• a production code (Production Identifier – UDI-PI) 

These components provide access to useful information about the device. The specificity of the UDI

• makes the traceability of products more efficient
• simplifies the recall of medical devices
• combats counterfeiting
• improves patient safety
   

The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices." (European Commission 2023)

• A globally uniform system for the identification of medical devices.
• The UDI marking is assigned and affixed in machine-readable (AIDC) and human-readable plain text (HRI) form to the label or product at the packaging level. If both formats - AIDC and HRI - cannot be accommodated for reasons of space (product direct marking/packaging), the AIDC format is preferred. For Class I disposable products and where there is a significant lack of space, the labelling shall be applied to the first level of packaging.
• Reusable devices and implantable devices (reprocessable) carry the UDI carrier (DataMatrix, plain text), where possible on the device itself (requirements EU Regulation 2017/745 transition period).This marking must survive the maximum number of reprocessing cycles so that the legibility of the marking is guaranteed throughout the expected lifetime of the product.
• The coding according to UDI has been mapped on the product label with the DataMatrix since 26.05.2021.
• Direct labelling with UDI will be applied where relevant in the context of regulatory requirements and the transition from MDD to MDR.

¹European Commission 2023: Unique Device Identifier (UDI), European Commission, [online] https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_de [retrieved on 19.06.2023].