Moderator: Jana Grieb, Counsel, McDermott Will & Emery
MDR has called for more stringent safety and data requirements for devices distributed in the EU. Initially set for application in May 2020, the new regulations had been unclear as notified body capacity appeared insufficient and some technical questions were still pending. How have MedTech companies been reviewing their implementation strategy now that the EU MDR application has been postponed by one year? What are the opportunities and consequences offered by postponement? How does this delay influence your choice to go to CE Mark or not? How to manage the three challenges MDR, COVID-19 and Brexit that the European medtech industry faces at the same time?