Gartner Research

Global UDI Requirements for Medical Device Companies Pose Supply Chain Challenges and Benefits

Published: 29 May 2015

ID: G00276711

Analyst(s): Andrew Stevens


Manufacturers and healthcare providers face significant supply chain challenges at a country level for new and anticipated 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



  • Immediately Target Compliance Activities for Mandated Physical and Data Requirements for the U.S. Final Rule
  • Develop Expertise to Ensure Thorough Understanding and Long-Term Compliance With the U.S. Final Rule
  • Identify Future Opportunities for Business Enablement Through the UDI "Access Key"

Gartner Recommended Reading

©2021 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner is a registered trademark of Gartner, Inc. and its affiliates. This publication may not be reproduced or distributed in any form without Gartner’s prior written permission. It consists of the opinions of Gartner’s research organization, which should not be construed as statements of fact. While the information contained in this publication has been obtained from sources believed to be reliable, Gartner disclaims all warranties as to the accuracy, completeness or adequacy of such information. Although Gartner research may address legal and financial issues, Gartner does not provide legal or investment advice and its research should not be construed or used as such. Your access and use of this publication are governed by Gartner’s Usage Policy. Gartner prides itself on its reputation for independence and objectivity. Its research is produced independently by its research organization without input or influence from any third party. For further information, see Guiding Principles on Independence and Objectivity.

Already have a Gartner Account?

Become a client

Learn how to access this content as a Gartner client.