European Union: Adopted AI Act including conformity assessment and business registration requirement for "high-risk AI systems" by Council

On 21 May 2024, the Council of the European Union adopted the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence 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. The Act will come into effect 20 days following its publication in the Official Journal and will be implemented 24 months after it enters into force. Chapters I and II will apply 6 months after the Act's effective date. Chapter III, Section 4, Chapter V, Chapter VII, Chapter XII, and Article 78 will be implemented 12 months after the Act comes into effect.