New EU Medical Device and Diagnostics (MDR IVDR) Regulations

Recorded Webinar

The European Parliament just adopted the Medical Devices (MDR) and In vitro Diagnostic Medical Devices (IVDR) regulations. The adoption marks another hallmark event in the global medical device identification initiative to achieve standardized medical device identification, improved device quality and better patient safety.The new regulations also mean time is ticking for medical device manufacturers selling devices in the EU to comply. USDM’s UDI Services and Solution VP and former lead for the UDI Initiative at the US FDA, Jay Crowley is the featured speaker.

The discussion will include:

  • UDI requirements in the MDR and IVDR
  • Timelines
  • Differences between US UDI requirements and the MDR and IVDR requirements
  • Status of the implementation and EUDAMED systems
  • Solutions, processes and best practices we see in the industry as companies begin to understand and prepare for MDR and IVDR and other UDI initiatives
  • 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.

 

 

 

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  • Clintrak - Jeffrey D. Coffin
    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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