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Webinar Registration

EU MDR's Impact on Labeling:

UDI in Europe and Other Changes

Thursday, May 24

11:00 AM New York 
4:00 PM London

1 hour duration

Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about what the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) mean for labels in this free webinar.


The new EU MDR/IVDR regulation puts labeling in a prominent position. It is critical for regulatory, labeling and operational professionals to gain a clear understanding of the impact of the new regulations on labeling.


The new regulations affect label formats, IFU information, and symbols, directly impacting operational labeling management and how organizations process data and manage their output. Though EU MDR is similar in many ways to the existing MDD and FDA UDI requirements, it is important to understand what is different. 


We will also discuss the submission requirements of the new EUDAMED database and how to align label content with data record submissions.

Key Learning Objectives
  • Label requirements comparison EU MDR vs MDD and AIMDD
  • Comparison of EU MDR & FDA UDI
  • Information on the label – what has to be changed?
  • Label – before and after EU MDR/IVDR
  • ROI – Label Mass Change
  • Barcode considerations
  • Alignment of your label content with your EUDAMED data record submission

About the Presenters:

 

Mark-CusworthMark Cusworth, VP Research and Development, PRISYM ID, has more than 15 years of experience heading up a team providing off-the-shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization.

His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead in-house research and development.

 

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Gary Saner, Sr. Manager of Information Solutions, Reed Tech, is a subject matter expert on UDI and other structured content submissions to regulatory agencies.

Gary has over a decade of experience in the Life Sciences industry and has worked for more than 30 years in the areas of software development, process management and data conversion.

 

About PRISYM ID

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PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors.

Learn More at PRISYMID.com

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Please note that the sponsors may contact you with further information about their products and services.