Unique Device Identification (UDI) Requirements for EU

This webinar will cover the proposed European Unique Device Identification (UDI) requirements from the MDR and IVDR for medical devices distributed in the EU. The event will include information on the proposed UDI requirements and the compliance deadlines. You will also have an opportunity to ask our UDI team questions.

The discussion will include:

  • Overview of EU UDI regulation
  • Broad overview of UDI
  • Obligations of responsible parties
  • Implementation timing
  • Live Q & A session

Who should attend?

  • UDI Team Leaders/Members
  • Regulatory Leaders/Teams
  • Manufacturing, Operations and Supply Chain Logistics
  • UDI IT Support
  • Distributors with UDI Submission Responsibilities

About the Presenters:

Jay Crowley 6Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

 

 

Rodolphe Munoz 2Rodolphe Muñoz is Director, European Board of Advisors at USDM Life Sciences. He focuses exclusively on providing business process, technology and compliance solutions for regulated life science companies conducting business in Europe.  He spent 3 years at DG SANCO (Health and Consumers) where he was in charge of medical devices and the establishment of the European UDI. He also was the representative of the EU for the UDI GHTF Working Group. 

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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