Medical device manufacturers distributing products in Europe have less than a year to comply with the European Medical Device Regulation.
To complicate matters, the requirement includes products already being distributed. For many manufacturers, there is still some uncertainty about what exactly needs to be done to comply and what data attributes need to be submitted to the EUDAMED. And, with more countries planning for their own unique device identification requirements, the challenges aren’t going away anytime soon. During this webinar, you will learn what steps you can take now to more easily comply with upcoming deadlines and future regulations.
The discussion will include:
Date of Application
- Challenges medical device manufacturers are facing as they tackle EU MDR and IVDR compliance
- Latest information on the technical specifications for the EUDAMED
- Strategies for dealing with future global UDI regulations
- Timeline for future UDI related regulations
- Live Q & A
26 May 2020 MDR
26 May 2022 IVDR
*This webinar was recorded prior to the European Commision MDR/IVDR deadline delays. Read 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.