We strongly encourage health authorities implementing (UDI) regulations to harmonize their UDI requirements
in line with the (IMDRF) UDI guidance*. This will ensure global harmonization and facilitate compliance
across the medical device and IVDs industry, when it comes to leveraging:
- an internationally accepted UDI coding system (e.g., GS1, HIBCC, or ICCBBA),
- IMDRF UDI labeling recommendations, and
- the IMDRF identified UDI-DI triggers for updates.
When implementing UDI regulation, Health Authorities should implement UDI through a phased-in and riskbased
approach beginning with the highest risk products. Health Authorities should implement a globally
harmonized and automated UDI data submission process.
While existing UDI regulations date back to the US FDA in 2012 and device manufacturers have been
calibrating their systems to these requirements since then, the purpose of this document is to provide
recommendations for future Unique Device Identification regulations.
While we support, in general, the guidance from the IMDRF, these recommendations provide additional details
that will benefit patients, hospitals, health care professionals and manufacturers.
