Article
UDI Labeling Requirement for Class I Devices
For Class I medical devices, the requirement to include the UDI code on labels comes into effect on May 26, 2025. Class I encompasses most low-risk medical devices compliant with Regulation (EU) 2017/745. Manufacturers of these devices must clearly display the UDI code in both human-readable and machine-readable formats (e.g., barcode or data matrix) to enable easy electronic traceability of the medical device.
Context
Regulation (EU) 2017/745 introduced significant changes to make medical devices safer and improve their traceability. One of the main innovations is the UDI system (Unique Device Identification), which is an identification code that allows for the unique recognition of a medical device and its manufacturer.
The UDI enables healthcare facilities, doctors, patients, and competent authorities to trace a device’s origin, know its production date, and identify its distribution chain, contributing to improved safety and simplifying potential recalls.
The medical device regulation has provided for a gradual introduction of the UDI labeling requirement, differentiated by device class. For Class III and implantable devices, the requirement has been in effect since May 2021; for Class IIa and IIb devices, since 2023.
Class I devices are the last, with the labeling requirement coming into effect in May 2025.
Implications for Manufacturers
The mandatory UDI code labeling necessitates a revision of device labels and packaging, as well as the need to update technical documentation and register the UDI in Eudamed.
For this reason, we have made available to manufacturers two articles that serve as a comprehensive and exhaustive guide on UDI code labeling:
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