EU MDR’s Impact on Labeling: UDI in Europe and Other Changes
Date: Thursday, 24 May 2018, 11:00 AM EDT/4:00 PM BST, 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
MEET OUR SPEAKERS
Mark Cusworth, VP Research and Development, PRISYM ID
Mark has over 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 the company in-house research and development.
Gary Saner, Sr. Manager of Information Solutions, Reed Tech
Gary 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.