The UDI system (Unique Device Identification) has been implemented to ensure the traceability of medical devices within the European Union. Before placing a device on the market, manufacturers must:
- Assign a Basic UDI-DI and a UDI-PI.
- Place UDI carriers on the device label.
- Submit the information to the European database EUDAMED.
Where Do We Stand With UDI Implementation?
The adoption of the UDI system is progressing slowly, as highlighted by Giada Necci, New Solution Specialist at GS1 Italy, during her speech at the AboutMedicalDevices conference. After an initial peak, the process has reached a standstill, with many companies still waiting to achieve compliance. Legacy devices, those already on the market, will only be integrated in the coming years. However, in the IVD sector (in vitro diagnostic devices), there is growing interest, with companies starting to inquire about the process.
Manufacturers can be divided into two main categories:
- Large Enterprises: Already prepared, these companies have acquired the necessary expertise to implement UDI codes.
- Small and Medium Enterprises (SMEs): These companies appear more disoriented and require greater support to meet the requirements.
Simultaneously, new stakeholders in the supply chain, such as healthcare institutions, are showing interest in the UDI system, seeking to understand its functionality and potential applications.
UDI and EMDN: A Unified Traceability System for Medical Devices
The UDI system integrates with EMDN (European Medical Device Nomenclature), the European nomenclature for medical devices used for EUDAMED registration. This synergy promotes uniform traceability, enabling all stakeholders in the supply chain – including patients – to “speak the same language.”
EUDAMED: A Challenge for Registration
Currently, EUDAMED contains approximately 500,000 registered devices, but by 2026, it will need to include 3 million. This represents a significant challenge for manufacturers, who must complete around 120 fields for each device without a “duplicate” function. While bulk uploads can be performed using structured electronic messages, this process is not always straightforward.
The quality and consistency of the data entered are critical to ensure the system functions correctly, requiring a substantial investment of time and resources.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
