Ask the Experts: Insights to Transition Timelines for Placing Legacy MD/IVD Products on the EU Market
Recorded March 07, 2024
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Ask the Experts: Insights to Transition Timelines for Placing Legacy MD/IVD Products on the EU Market
Ask the Experts:
Insights to Transition Timelines for Placing Legacy MD/IVD Products on the EU Market
This free, live webinar is the first of a three-part series that will help guide medical device manufacturers through their EU MDR/IVDR implementation plan. This information-packed webinar focuses on the requirements, timing, and strategy of placing EU Legacy Devices on the market through the transition period. The MDR/IVDR Dates of Application have passed. As a medical device manufacturer, you should be briskly walking down your transition path toward compliance and meeting the looming timing milestones. This webinar will be invaluable if you haven’t started your journey or if you have started and need to check your compass to make sure you are on course to meet the frequently changing requirements and timelines. Based on their respective experiences, Dr. Bassil Akra and Gary Saner will reveal best practices to follow and roadblocks to avoid for medical device manufacturers navigating through the EU Legacy Device migration period.
Key Takeaways:
Get clarity on the EU Legacy Device transition framework
Learn the critical effects of the Legacy Medical Device transition resulting from Regulation (EU) 2023/607
Understand the impact to the Legacy IVD transition expected from the recently proposed legislation (EU) 2024/0021/COD
Acquire strategy insights to facilitate the EU Legacy Device transition period
Who does this apply to:
Global Strategy Business Managers
Regulatory Affairs/Operation Leaders
Product Managers and Business Analysts
Manufacturing, Operations, and Supply Chain Leaders
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Dr. Bassil Akra
LinkedIn
Dr. Bassil Akra is the CEO and Owner of AKRA TEAM, a globally acting consultancy company. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR, and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.
Gary Saner
LinkedIn
Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
Life Sciences Solutions Driven by Accuracy and Insight Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.
