Gartner Research

Assessment of Unique Device Identification (UDI) Requirements for Medical Device Companies, Worldwide

Published: 26 February 2016

ID: G00295492

Analyst(s): Andrew Stevens

Summary

Manufacturers and healthcare providers face significant global supply chain challenges and opportunities with existing and developing Unique Device Identification requirements. Supply chain leaders should act urgently to ensure compliance, while investigating the many benefits of UDI capabilities.

Table Of Contents
  • Key Challenges

Introduction

Analysis

  • Regulatory Focus
    • U.S.
  • IMDRF Collaboration Setting Initial Frameworks for Further Legislation Maturity
    • Europe
  • Convenience Kits
  • Direct Marking

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