Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI
Labeling Webinar Series - A Date with the Experts on Global Labeling Systems
Join us for this 60-minute information packed webinar on ‘Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI’ to discover why EU MDR will change the medical device labeling landscape globally and how to best meet the impending challenges.
Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the new EU MDR (European Medical Device Regulation).
The final directive (published May 5th 2017) aims to establish a robust, transparent, predictable and sustainable regulatory framework allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. As part of this process, labeling will be key.
EU MDR is being viewed as an extension of the FDA’s UDI (Unique Device Identification), but also a ‘step up’. However, it’s more detailed and more complex due to the local language requirements needed for Europe. Organizations - having just completed the hurdles of UDI compliance– need to embrace the lessons learnt and incorporate them into their labeling strategy to make bridging the gap easier in this new legislative landscape.
Key Learning Objectives:
- Understand what EU MDR compliance means for your business and how it will affect your labeling processes
- Develop an understanding of the market’s perceptions of EU MDR
- Recognize what the biggest labeling compliance challenges ahead are and how to proactively overcome them
- Embrace the lessons learn from UDI to work smarter in meeting the implementation deadlines of MDR by May 2020 and IVDR by May 2022
- Learn about a labeling system that can adapt to regulations that will be following for other countries that are not part of the US or EU, so that any new regulation does not have a similar size impact
MEET OUR SPEAKERS
Andrew Love, Be4ward
Andrew Love is a multi-award-winning packaging and artwork management strategist, leader and author.
Andrew spent 10 years as head of global packaging design operations at GlaxoSmithKline, the world’s second largest pharmaceutical company at the time. During his time there he oversaw the transformation of the global artwork management activities into a world-class, award-winning capability.Andrew is one of the founders of Be4ward which helps pharmaceutical, biotech and other healthcare companies and their supply base to improve patient safety and drive additional value from their product range. He now develops products for, and works with, a number of pharmaceutical and healthcare companies in achieving these aims.Andrew, a professional engineer and MBA with over 20 years of experience, has worked with many of the world’s largest life-sciences companies.
Mark Cusworth, PRISYM ID
Mark Cusworth is the VP Research and Development at PRISYM ID. He 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 in order to maintain the market leading position of PRISYM ID’s world class label management software.