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WEBINAR

Part II: EU UDI and Legacy Devices

Thursday, August 19th at 11am ET / 4pm London

Register to view the recording Part II of What to Know About EU UDI and the category of legacy medical devices

View the recording for for Part II of What to Know about EU UDI and the category of Legacy medical devices.

In Part I, we covered a deep dive of into the published guidance on Legacy devices. As the MDR DoA (date of Application) has now passed, these are the devices that (if they meet specific criteria), can continue to be placed on the market for a period of time. As medical device manufacturers transition from the Medical Device Directives (MDD/AIMDD/IVDD) to the new regulations of the Regulation (MDR/IVDR), a new set of compliance rules and requirements come into play. We will do an in-depth walk-through of a ‘business use case’, describing the scenario, options and timelines. Registration of Legacy device versus Regulation compliant devices will also be reviewed.

This 30 minute presentation covers a business use case as one company assesses next steps based on their portfolio and sets expectations for MDR activity. Incoming questions from webinar Part I (recorded July 20, 2021) will also be discussed. We will review the following:

• Questions and comparisons of Regulation and Legacy Devices registration requirements
• MDR/IVDR Equivalent devices
• Business Use case

Key Takeaways

For regulatory teams working on EU MDR/IVDR data, this webinar will be a helpful walk-through of the main takeaways in the published information from the European Commission and the Medical Devices Coordination Group concerning Directive Devices that will continue to be placed on the market.

Who Does This Apply To?

  • Global Strategy Business Managers
  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations, and Supply Chain Leaders
  • Quality Leaders
  • IT Support

Panelists

  • Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

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Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

Clean & Elegant
Fully Responsive

Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.

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.