Update on Global UDI Initiatives for Medical Devices

Overview

This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the new EU MDR, the NHS e-procurement and PEPPOL programs in the UK, and the development of initiatives in other countries including Australia, Canada, Japan and Asia.

Unique identification and barcoding are neither new technologies nor innovative concepts. But incorporation of UDI into the medical device industry has been long discussed and planned and slow to be implemented.

What has taken this major industry so long to adopt UDI and barcoding? Why are both manufacturers and hospital systems reticent about implementing it?

Why Should You Attend

Knowledge, planning, preparation. These are the foundation principles for any successful and sustainable project, especially one as global and multi-faceted as Unique Device Identification. It is never too soon to begin increasing your awareness of the various programs being established and your knowledge of the requirements and timelines to help you begin planning and preparing for what is inevitably going to be a challenging, resource-heavy, and time-consuming process.

Medical device manufacturers of all sizes, locations, product class, and expertise are in the same precarious position of uncertainty and waiting. By strengthening your UDI intelligence now, you will be better positioned to lead your organization in this global initiative.

Areas Covered in this Webinar

• Intent of Unique Device Identification regulations
• Why are countries creating regulation for UDI?
• What is the purpose of the regulation?
• Current efforts & hurdles to harmonization
• Key differences in proposed regulations
• Standards
• Label requirements
• Data reporting
• Comparison of IMDRF/ US FDA/ EU
• Timelines – known & anticipated
• Impact of UDI on global trade & commerce, product cost, and patient safety
• Enforcement actions

Learning Objectives

• Be aware of what UDI information to look for and where to find it
• Be able to outline a general UDI strategy by identifying and prioritizing the “critical to business” regulations you need to address first

Who Will Benefit

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Labeling Specialists
• Master Data Managers
• Supply Chain Professionals

Others Details

Impact of UDI on global trade, how to create a globally sustainable UDI program and challenges for medical device identification