What to know about EU UDI and Legacy Devices

Recorded Tuesday, July 20th at 11am ET / 4pm London

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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. Understanding the applicable scenarios, provisions for registration and the timing for each become important.

This presentation will cover ‘what to know’ concerning the category of ‘Legacy Devices’. Now that the MDR Date of Application has passed, these are the devices that (if they meet specific criteria), can continue to be placed on the market for a period of time. Legacy device registration is handled differently than Regulation compliant devices.

We are taking a deep dive into the published guidance and will illuminate some key areas:
• Legacy Directive Device definition, criteria and requirements
• MDR/IVDR Equivalent devices
• Compliance timelines based on scenario
• Legacy device reporting to the 6 modules of EUDAMED
• Compare Regulation and Legacy Devices registration requirements
• Compare and contrast Basic UDI-DI and UDI-DI to EUDAMED-DI and EUDAMED-ID
• 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


  • Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
  • John Lorenc, Director Product Management, Medical Devices, 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.

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Fully Responsive

John Lorenc directs electronic submission and regulatory requirement initiatives that impact the medical device industry. He has advanced experience with machine-to-machine submission requirements to global UDI databases, including US FDA GUDID, EU EUDAMED, and China NMPA UDID. John represents Reed Tech in membership with MedTech Europe, and actively participates in electronic submission pilots to regulator UDI databases.

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.

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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.