European Commission opens public consultation on long-awaited draft for high-risk AI guidelines

The European Commission has published its long-awaited draft guidance on the classification of high-risk AI systems and has opened a public consultation.

The guidelines aim to help assess whether an AI system should be classified as high-risk; either intended to be used as a safety component of a product, or carrying the potential to endanger health, safety or fundamental rights. If they do, they need different treatment under Article 6 of the AI Act.

"The guidelines are intended to support providers, deployers, and other relevant actors in determining whether an AI system falls within the high-risk category," the Commission explained.

"They offer clarifications on the relevant provisions of the AI Act and include practical examples to illustrate how the classification should be assessed in different areas and use cases."

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The guide comes in two parts, with the first covering AI systems that are themselves products, or safety components of products, under sectoral harmonization legislation, including the Machinery Regulation, the Toys Safety Regulation, the Radio Equipment Directive, medical devices, and the automotive and aviation regimes.

The second, meanwhile, covers AI systems that can significantly affect people's health, safety, or fundamental rights in specific use cases listed in the AI Act.

Article 6(3), covering the significant risk of harm to health, safety, or fundamental rights, is where most providers will go wrong, said Patrick Sullivan, VP of Strategy and Innovation at compliance provider A-LIGN.

There's a carve-out with four conditions – that the AI performs a narrow procedural task, improves the result of a previously completed human activity, detects decision-making patterns or deviations without replacing or influencing the human assessment, and performs a preparatory task to an Annex III assessment.

But, said Sullivan, hard exception applies, with an Annex III system is always high-risk where it performs profiling of natural persons. "This matters enormously for HR systems, credit decisioning, and any system that builds individual-level predictive profiles," he warned.

The document has been significantly delayed, having been expected to be published back in February; and following the political agreement on the AI Omnibus, there's a new enforcement timeline.

Rules for systems used in certain high-risk areas – including biometrics, critical infrastructure, education, employment, migration, asylum and border control – will apply from 2 December 2027, while for systems integrated into products such as robotics and industrial machinery, they'll come into effect on 2 August 2028.

The Commission is now holding a consultation on the guidelines, aimed at anyone with an interest in the development, deployment, supervision or use of AI systems is invited to contribute.

"This includes AI providers and developers, organisations using AI systems, public authorities, researchers, civil society organisations, supervisory bodies and members of the public," it explained.

The consultation is open until 23 June.