The EU Artificial Intelligence Act (AIA) is the world’s first comprehensive AI law and is set to transform how AI-enabled medical devices are developed, approved, and brought to market. For manufacturers, regulatory teams, and innovators, understanding the new requirements is critical to ensuring both compliance and competitiveness in the European market.

This webinar, hosted by BSI Group and McDermott Will & Schulte, will bring together legal, regulatory, and technical experts to provide clarity on what the AIA means in practice. You’ll gain a clear understanding of the obligations facing AI developers, manufacturers, and deployers, as well as the strategic considerations for legacy devices already on the market.

Key discussion points include:

• Key definitions and classification aspects for high-risk AI systems
• Compliance obligations for AI-enabled medical devices
• Practical steps to align with expectations on transparency, data governance, and human oversight
• Preparing for certification and interaction with notified bodies
• Options for legacy devices and grandfathering provisions

Who should attend:

This session is designed for professionals across the medical technology and healthcare sectors, including:

• Medical device manufacturers and suppliers
• Regulatory and compliance leaders
• AI innovators and technology developers
• Legal, Compliance and Regulatory Affairs professionals
• Hospitals and health systems deploying AI medical devices

Why attend:

With the AIA now in force, businesses entering or operating in the EU market must act quickly to adapt. This session will equip you with the knowledge and practical guidance to position your organization for compliance while continuing to innovate with confidence.

Click here and register now to secure your place and prepare your business for the future of AI-enabled healthcare.