By 26thMay 2025, manufacturers of certain medical devices must ensure that the UDI carrier is correctly affixed to the device, label or packaging. These include:
- Class I Medical Devices
- Class IIa & IIb reusable devices (direct marking)
- Class B & Class C IVD devices
This deadline is a critical step in the full implementation of the Unique Device Identification (UDI) system, aimed at enhancing the traceability, safety, and post-market surveillance of medical devices across the European Union. The MDR requires that all medical devices bear this information so they can be easily and accurately identified throughout the supply chain and in clinical settings.
The UDI carrier refers to the physical application of the UDI on the device’s label and packaging. In accordance with the MDR, the UDI must appear in a plain-text version/human readable information (HRI) and in a form that uses AIDC technology. AIDC means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or another computer system via an automated process. The HRI consists of legible characters that can easily be read by people.
An example of how the UDI Carrier should be represented on the label can be seen below.
We would like to remind manufacturers that failure to comply could result in non-conformities raised during audits, disruption in placing products on the EU market, or even regulatory action.
Should you have any queries regarding the UDI Carrier, please don’t hesitate to contact us.
