The IMDRF Unique Device Identification (UDI) framework was developed to improve patient safety, support rapid device identification, enhance supply chain efficiency, reduce regulatory burden and enable global interoperability.
Following feedback from regulators, industry, UDI issuing agencies, and other stakeholders on the challenges of global UDI implementation, the IMDRF Management Committee requested that a workshop be held to explore the key drivers of divergence and identify opportunities to improve alignment.
The workshop brought together regulators, industry representatives, UDI issuing agencies and international organisations.
This document provides a summary of the workshop discussions.