For many medical device manufacturers, there is still some uncertainty about what data needs to be submitted to the European Database on Medical Devices (EUDAMED) to comply with the European Union Medical Device Regulation (EU MDR). There are also new label requirements, which means most manufacturers will need to make changes to the content on their device labels.
The discussion will include:
Watch our webinar to get a better understanding of what you need to do prior to May 26, 2020 and how an Enterprise Labeling Solution can assist with your EU MDR compliance.
- Devices impacted by EU MDR
- Types of data that must be submitted to the EUDAMED
- Label implications and requirements
- Connecting EU MDR data to your labels across your Enterprise and Supply Chain
- Enterprise Labeling Solutions overview
- Timelines and strategies
- Live Q & A
*This webinar was recorded prior to the European Commision MDR/IVDR deadline delays. Click here for the most recent updates.
About the Presenters:
Vice President of Unique Device Identification Solutions 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.
Labeling Specialist at Loftware Joe has spent the bulk of his career selling automated supply chain solutions to the Life Sciences industries.