Gartner Research

Assessment of Unique Device Identification Requirements for Medical Device Companies, Worldwide

Published: 29 August 2016

ID: G00302228

Analyst(s): Andrew Stevens


Supply chain leaders and strategists across medical device manufacturers and healthcare providers must maintain continued vigilance on developing global UDI requirements and its future potential.

Table Of Contents



  • Recommendations for Global UDI Planning, Compliance and Strategy
    • Regulations, Implementation and Execution
  • IMDRF Collaboration Setting Initial Frameworks for Further Legislation Maturity
  • Global Landscape for Regulation for UDI
    • United States
  • Recent Updates, Information and Developments Impacting FDA UDI Regulations
    • Access GUDID
    • Form and Content of UDI; Draft Proposals/Guidance Documents, July 2016
    • National Evaluation System for Health Technology (NEST) and UDI
  • Direct Marking
  • Convenience Kits
  • Compliance Requirements for U.S. FDA UDI Legislation
    • Regulatory Implementation Timelines for U.S. Requirements
    • Europe — the European Union (EU) and European Economic Area (EEA)
    • EU MDR Regulations
    • European Database for Medical Devices (EUDAMED)

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