On 2 August 2026, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) comes into effect for "high-risk AI systems" referred to in Annex III of the Act. The Act includes conformity assessment and business registration requirements for "high-risk AI systems", contingent upon meeting a set of requirements and obligations for entry into the EU market. The Act includes obligations related to data quality and technical documentation with the aim of ensuring that small and medium-sized enterprises are able to demonstrate compliance with the requirements for their high-risk AI systems. Furthermore, the Act empowers individuals by allowing them to file complaints with relevant market surveillance authorities regarding non-compliance with the AI Act. In terms of enforcement, the AI Act introduces fines for violations, calculated as a percentage of the offending company's global annual turnover. The fines are tiered, EUR 35 million or 7% for prohibited AI applications, EUR 15 million or 3% for violations of the Act's obligations, and EUR 7.5 million or 1.5% for supplying incorrect information. For high-risk AI systems as defined by Article 6(1), the Act only applies from 2 August 2027.
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