The European Union's recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically designed for AI, with a particular focus on the healthcare sector. This commentary provides an overview of the key elements of the AI Act, highlighting its significance and implications for medical AI applications. The AI Act, adopted by the EU's 27 member states on March 13, 2024, aims to promote human-centered and trustworthy AI while protecting individuals from potential harm. It sets harmonized rules for the market introduction, use, and service of AI systems, becoming binding law in all EU Member States 20 days after its publication. The Act applies to all providers of AI systems in the EU market, regardless of their location, and extends to third countries if the output is used in the Union. For the healthcare sector, the AI Act is crucial because existing harmonization legislation, such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), do not explicitly cover medical AI applications. The Act includes a risk-based approach, prohibiting certain AI practices with unacceptable risks and classifying high-risk AI systems and general-purpose AI (GPAI) models. It also provides exemptions for medical uses and promotes innovation through regulatory sandboxes and open-source licenses. The Act's impact on the healthcare sector is significant, with many commercial AI-enabled medical devices classified as high risk under the MDR. This means that these devices must comply with the AI Act's requirements within 12 months of its coming into force. However, the effective implementation of the AI Act within existing sector-specific legislations, such as the MDR and IVDR, remains unclear, potentially complicating the authorization process. Overall, the AI Act aims to ensure the safe and fair development and implementation of AI across various industries, including healthcare. While it sets high standards for global AI development and use, ongoing reassessment and refinement of regulations are necessary to manage the rapid evolution of AI technologies and ensure equal market opportunities and consumer safety.The European Union's recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically designed for AI, with a particular focus on the healthcare sector. This commentary provides an overview of the key elements of the AI Act, highlighting its significance and implications for medical AI applications. The AI Act, adopted by the EU's 27 member states on March 13, 2024, aims to promote human-centered and trustworthy AI while protecting individuals from potential harm. It sets harmonized rules for the market introduction, use, and service of AI systems, becoming binding law in all EU Member States 20 days after its publication. The Act applies to all providers of AI systems in the EU market, regardless of their location, and extends to third countries if the output is used in the Union. For the healthcare sector, the AI Act is crucial because existing harmonization legislation, such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), do not explicitly cover medical AI applications. The Act includes a risk-based approach, prohibiting certain AI practices with unacceptable risks and classifying high-risk AI systems and general-purpose AI (GPAI) models. It also provides exemptions for medical uses and promotes innovation through regulatory sandboxes and open-source licenses. The Act's impact on the healthcare sector is significant, with many commercial AI-enabled medical devices classified as high risk under the MDR. This means that these devices must comply with the AI Act's requirements within 12 months of its coming into force. However, the effective implementation of the AI Act within existing sector-specific legislations, such as the MDR and IVDR, remains unclear, potentially complicating the authorization process. Overall, the AI Act aims to ensure the safe and fair development and implementation of AI across various industries, including healthcare. While it sets high standards for global AI development and use, ongoing reassessment and refinement of regulations are necessary to manage the rapid evolution of AI technologies and ensure equal market opportunities and consumer safety.