Understanding the integration of AI and ML technologies into IVD software devices

ABOUT THE WEBINAR

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into IVD medical device software is transforming diagnostics while introducing new regulatory challenges. Since the EU IVDR's introduction and its gradual application, ensuring compliance for AI/ML-enhanced IVDs has been a significant hurdle, often resulting in deficiencies during Notified Body assessments. In addition, The EU AI Act puts another layer of complexity to this regulatory landscape.

Key challenges in general include but not limited to, aligning AI/ML algorithms with intended purposes, maintaining transparent benefit/risk assessments, demonstrating clinical performance for AI-driven diagnostic tools, and navigating the intersection of IVDR and AI Act requirements.

In this webinar, hosted by TÜV SÜD and Entourage (website link: https://theentourage.de/en/), our professionals will discuss possible strategies for integrating AI/ML into IVD software while ensuring compliance with both the IVDR and the EU AI Act.

We will discuss:

• Unique aspects of AI/ML in IVD software

• Efficient methods to meet IVDR requirements for AI/ML-enhanced devices
• Implications of the EU AI Act for IVD software and how to prepare
• Leveraging existing evidence for AI/ML algorithm validation in legacy IVDs
• Implementing continuous performance evaluation for AI/ML software
• Harmonizing IVDR and AI Act compliance strategies

Join us to gain insights from industry professionals on understanding the integration of AI/ML in IVD software while maintaining regulatory compliance and ensuring the safety and performance of AI-driven IVDs in the evolving European regulatory framework.

Date: 05 December 2024, Thursday
Time:

Duration: 60 mins (45 mins panel discussion + 15 mins Q&A)

WEBINAR OUTLINE

Topic 1: Unique aspects of AI/ML in IVD software

Topic 2: Efficient methods to meet IVDR requirements for AI/ML-enhanced devices

Topic 3: Implications of the EU AI Act for IVD software and how to prepare

Topic 4: Leveraging existing evidence for AI/ML algorithm validation in legacy IVDs

Topic 5: Implementing continuous performance evaluation for AI/ML software

Topic 6: Harmonizing IVDR and AI Act compliance strategies

Conclusion & Q&A

SPEAKERS & MODERATOR