What is the webinar about?
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.
What will participants gain?
- 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.
Who should attend?
This webinar is designed for AI Medical Device and IVD manufacturers, Software as Medical Device (SaMD) developers and AI systems deployers. It is especially useful for business and technology leaders, compliance professionals, as well as legal professionals who need to understand the impact of the EU AI Act on their operations.
Speakers
To find out more about Artificial Intelligence and the EU AI Act, visit our dedicated AI webpage.
Email: medicaldevices@bsigroup.com
Phone: +44 3450809000
Follow BSI AI Regulatory Services on LinkedIn.
