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"Ethical and trustworthy Artificial Intelligence"

What medical device producers should know about the European Artificial Intelligence Draft Act (AIA)

Additional regulation of AI-based Medical Devices (MDs) and In Vitro Diagnostics (IVDs) is progressing under the EU’s Artificial Intelligence Act (AIA). This paper explores this soon-to-be adopted regulatory framework as well as existing standards that will need to be harmonized, particularly for High Risk devices.

What you will learn:

• The definition of AI and the scope of products that fall under the AIA
• What the AIA classifies as High and Low Risk
• Requirements and obligations for device manufacturers marketing into the EU
• The role of notified bodies.

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