Artificial intelligence (AI) represents a global phenomenon changing all spheres of human life. Biomedical engineering is no exception, as many AI systems are applied to biomedical engineering inventions. The European Union has enacted the new EU AI Act, one of the world’s first laws on AI. The main topic of this research is to examine what changes this new regulation brings to AI development in the field of biomedical engineering. An AI system applied in biomedical engineering is often considered a high-risk AI system, which means that AI developers are bound by a set of requirements and obligations to achieve a trustworthy, human-centric AI system. The authors analyze the impact and appropriateness of these requirements for developing AI systems in biomedical engineering using the legal dogmatic method, as well as by analyzing the secondary sources in the literature. The authors aim to present the current situation in AI regulation and make suggestions for further development.