Webinar: EU AI Act – New requirements for medical devices

The implementation of the EU AI Act is now underway, and manufacturers of medical devices and in vitro diagnostic devices must begin preparing for a new set of regulatory requirements. AI systems used in medical devices are generally classified as high-risk AI systems, meaning that compliance with both the EU AI Act and the applicable MDR or IVDR requirements will become increasingly important.

For manufacturers of medical devices and in vitro diagnostics, this raises a set of important questions. In this free webinar, we will try to answer some of them. Our expert Thora Markert will provide an overview of the EU AI Act and its implementation timeline. You will gain insights into the regulatory requirements for AI medical devices and IVDs, the overlap between the EU AI Act and existing medical device legislation, and practical steps manufacturers can take to prepare for compliance.

Topics covered in this webinar:

• Overview of the EU AI Act and current implementation status
• Overlap between the EU AI Act and the MDR/IVDR
• Requirements of the EU AI Act for medical devices
• Role of certification bodies
• Practical tips & preparing for the new requirements

This webinar is designed for medical device industry professionals and executives who deal with regulatory requirements, product classification, and conformity assessment procedures.

It is particularly suitable for:

• Medical device manufacturers
• Professionals responsible for AI-based medical devices
• Quality managers
• Regulatory affairs managers
• Individuals responsible for approval and conformity assessment