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AI applications that have a significant potential to harm the health, safety, or fundamental rights of individuals, triggering the most stringent compliance requirements under the EU AI Act.
High-risk systems are determined either by their integration into Annex I products or their use in sensitive areas defined in Annex III (e.g., education, employment, critical infrastructure). Providers of these systems must implement an ongoing Risk Management System (RMS), maintain high-quality datasets, and produce comprehensive technical documentation before deployment.
Real world example:
A fintech company uses an AI system to evaluate creditworthiness for mortgages; this is classified as a High-Risk system under the Essential Private Services category of EU AI Act Annex III.




