In order to continue distributing devices in the EU after 26 May 2020, many of the new EU Medical Device Regulation’s (MDR) requirements must be fulfilled. Although some guidance and specifications are still forthcoming, there are several known remediation activities that can – and should – be started NOW. Join us to learn strategies for starting to address and comply with this complex new regulation.
The discussion will include:
- Leveraging your current US UDI activities for the EU MDR
- Updating your systems and processes so that you can continue to distribute devices with a valid MDD/AIMD certificate
- Understanding the significant new requirements for most class I devices (no “grace period”)
- Live Q & A session
Vice President of Unique Device Identification 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.