Overview

As the Artificial Intelligence Act (AIA) is expected to enter into force in 2024 and be applicable in 2026, planning for its implementation should start now. The horizontal nature of the AIA means that it will interplay with the MDR, where tensions and inconsistencies are likely to emerge. In particular, the AIA requires a single conformity assessment procedure for AI-enabled medical devices covered under the MDR. Therefore, for developers of AI-enabled medical devices, the AI Act poses several challenges, including additional obligations related to testing, risk management, post-market monitoring and documentation.

Key takeaways and learning objectives

Key webinar topics:

• An understanding of gaps regarding specific requirements of AI conformity assessment.
• Clarity on the EU AI Act's significant impact on the medical devices industry as well as ongoing debates.
• Enhanced insights on issues of AI-enabled medical devices' model changes that may be considered as substantive modification and therefore trigger a new conformity assessment.

Presenter information

Speaker - Aris Tzavaras, Head of AI Notified Body at BSI

Speaker - Alex Laan, Head of IVD Notified Body at BSI

Speaker - Suzanne Halliday, VP Regulatory at BSI

Speaker - Inma Perez, Regulatory Lead - AI Notified Body at BSI