On-Demand EU Medical Device and Diagnostics (MDR) 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 MDR discussion will include:
- UDI requirements in the MDR and IVDR
- 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
*This webinar was recorded prior to the European Commision MDR/IVDR deadline delays. Click here for the most recent updates.
About the Presenter:
Vice President of Medical Device Solutions and Services 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.