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New European Union Medical Device Regulations Webinar Replay

Event Date: 
Tuesday, October 2, 2018
Registration Fee: 
Complimentary (available to DTA Members only)

Click here to register for the replay.

This webinar replay is presented by Jay Crowley, Vice President of Unique Device Identification Services and Solutions at USDM Life Sciences. The presentation explores the new rules and regulations for selling medical devices inside the European Union which will make it more difficult and expensive to have devices accredited to sell in Europe and new UDI labeling will force companies to re–examine their labeling and packaging of devices. Failure to absorb this new information may result in delays and extra fees to sell devices across Europe.

This complimentary webinar replay is for DTA Members only and covers the following topics:

  • Important information about having devices accredited and approved for sale in the E.U.
  • European Unique Device Identification
  • Changes to the Notified Bodies that audit/accredit the devices sold in Europe and other changes to the existing system
  • Paperwork and fees to have devices approved for sale in the E.U. (crucial to companies attending the next IDS meeting in March 2019)
  • Brexit and what challenges that may represent for U.S. manufacturers

Who should register?

  • Manufacturers that currently sell and those that wish to sell their devices in the E.U.
  • Distributors, laboratories, and companies looking for strategic partners or European distributors
  • Key staff working with regulatory affairs, exports, and international sales
About the Presenters: 

Jay Crowley

Vice President, Unique Device Identification Services and Solutions, USDM Life Sciences

Jay was most recently 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 FDA’s Unique Device Identification system.

At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.

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