[Emergo, UL] The European AI Act: Requirements for High-Risk AI Systems

Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.

Recap

The EU AIA  introduces a risk-based classification for AI systems. Medical devices employing AI (and ML) are likely to be classified as high-risk AI systems. This categorization imposes certain requirements based on AI best practices. Non-compliance with these requirements and indeed with the regulation can result in hefty fines being levied on medical device manufacturers.

For high-risk AI systems already on the market, the AIA shall only apply before the end of the stated transition period if there will be significant changes to the design or intended purpose.

The AIA imposes some additional requirements on economic operators (and operators) in the supply chain.

EU AI office is now open

Since our last regulatory update, the EU AI office has become operational. The AI office plays a key role in enforcement and oversight and sits within the EU Commission (EC). Amongst other tasks, it will enable the implementation of the AIA by supporting Member State governance bodies, enforce rules for GPAI models and promote collaboration amongst key stakeholders in the AI ecosystem. This will help foster a strategic approach to AI development that is innovative while also being safe and ethical in order to assure AI-enabled devices placed on the EU market are trustworthy.

 

 

The European AI Act: Requirements for High-Risk AI Systems | Emergo by UL

The European AI Act: Requirements for High-Risk AI Systems

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