The Compliance Journey Of High-risk AI Providers And Deployers

The designation of “high risk” AI systems in the EU's AI Act carries with it the most stringent obligations and is mainly where businesses need to focus their immediate compliance efforts. High-risk AI systems are generally those that pose a significant threat to health, safety, or fundamental rights. The Act broadly defines them in two ways:

1. AI systems intended to be used as a safety component of a product, or are themselves a product, covered by specific EU harmonisation legislation (e.g., medical devices, machinery, aviation) and require a third-party conformity assessment; and
2. AI systems falling into specific predefined areas listed in Annex III of the Act which include critical infrastructure management (road traffic, gas or water supply), education and vocational training (e.g., assessing learning outcomes), employment and worker management (e.g., recruitment, performance evaluation), access to essential public and private services (e.g., eligibility to