Post market surveillance under EU MDR - do I have to run a clinical study? What other options do you have to fulfill post market surveillance requirements; including updating CERs

Tuesday, June 5; 2 PM – 3 PM
Speaker: Jon Gimbel, Director and CER Business Unit Lead, Regulatory & Quality Solutions (R&Q)
Speaker introduction and moderation: Lisa Casavant, Executive Vice President, Regulatory & Quality Solutions (R&Q)

What is “sufficient clinical evidence”and what does it look like? This program will discussion options for sufficient clinical evidence, and the opportunities, risks, and challenges associated with each.The EU MDR lays out requirements for a proactive post-market surveillance system that that inputs into the ongoing risk management and clinical evaluation processes throughout the device life cycle. In this program we’ll also cover the requirements for the PMS system, PMS planning, and PMS reporting. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes.