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A notified body perspective.
What is sufficient clinical evidence and what does it look like as part of PMS?
The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. 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. The requirements seem to overlap with the CER requirements and risk management activities.
How can you optimize your processes to avoid duplication of efforts and maintain consistency throughout your quality management system? Are you really ready?
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