Strategy for Success: Master EU MDR Clinical Data Requirements

ABOUT THE WEBINAR

Join us for a comprehensive webinar designed to clarify the Medical Device Regulation (MDR). Our expert speakers will guide you through the evolution of MDR, highlighting key differences from previous regulations and the critical importance of compliance. We'll explore MDR clinical requirements (Article 61) and the harmonization with ISO 14155:2020, along with the innovation challenges in Europe compared to the FDA, including the difference in requirements related to FDA data and data requirements from other regions. This will increase your understanding as a medical device manufacturer on the topic of leveraging clinical data.  

Gain insights on MDR clinical data requirements with the view to prevent common pitfalls, and efficiently prepare and submit your MDR documentation. Learn how to work effectively with notified bodies and apply practical tips through real-world case studies. 

The second half of the webinar will be a panel discussion, offering you the chance to engage with experts from Industry as well as consultants and Notified Body. Ask questions, and gain information on requirements for navigating the MDR landscape efficiently. 

Duration: 90 minutes

Our webinar will tackle these points, focusing on:

• Data transferability - explanation of MDR clinical requirements (Article 61), overview of ISO 14155:2020
• Practical tips  First-hand best practices when it comes to working with a notified body.
• Increase understanding as medical device manufacture - leveraging clinical data – general examples of acceptable Art 61.10 cases.
• Panel Discussion

About the speaker