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This article analyzes the European regulation of artificial intelligence (AI) through the AI Act, adopted in March 2024, and its implications for companies whose products fall under the category of high-risk AI systems. This classification raises the question of the ambivalent effects of regulation on innovation: does it act as a brake or a driver for European competitiveness? It also highlights the issue of the EU’s strategic positioning in relation to the US and China, and its ability (or inability) to impose standards that are becoming unavoidable in the field of high-risk AI. AI is presented as a “Grand Challenge” for public policy, comparable to other global issues such as climate change, biodiversity, health, or demographic aging. The objective of this paper is to present the challenges related to innovation and the EU’s strategic positioning.