n April of 2017 the European Union introduced new regulations for Medical Devices and InVitro diagnostic medical devices. The new regulations contain a more robust framework for medical device manufacturers to ensure public health and patient safety. Understanding the EU MDR will help ensure a high level of safety and quality for medical devices being manufactured in, or sold to the European Union. The PathWise online training module covers the key changes in the updated regulation, and provides a framework to complete a Gap Analysis to ensure your organization is ready to transition to the new standard.