Gartner Research

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

Published: 29 August 2016

ID: G00302228

Analyst(s): Andrew Stevens

Summary

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

Introduction

Analysis

  • 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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