Published on July 12, Regulation 2024/1689, also known as the AI Act, establishes a comprehensive regulatory framework for AI, affecting all stakeholders, including those outside the European Union. Key Points to Remember 💡 Risk Classification: AI systems are now classified into four risk levels, ranging from unacceptable risk to minimal risk. High-risk systems, such as certain Medical Devices (MDs), will require specific measures, including human oversight and stringent technical standards. Conformity Requirements: For high-risk systems, implementing a Quality Management System (QMS) compliant with ISO 42001, developing technical documentation, and obtaining CE marking are mandatory. Crucial Deadline: Mark August 2, 2027, in your calendars, a critical date for the compliance of high-risk MDs with the AI Act.  Next Steps to Consider ➡️ Review the Complete Text of the AI Act to understand its implications for your organization. Evaluate Your AI Systems to determine their risk classification under the new regulation. Develop a Global Regulatory Strategy that integrates the General Data Protection Regulation (GDPR), the Medical Device Regulation (MDR 2017/745), and the In Vitro Diagnostic Regulation (IVDR 2017/746) to ensure comprehensive regulatory compliance. Engage a Notified Body to assess the AI aspect of your systems. Adapt Your Compliance Processes to meet the specific requirements for your AI systems. Prepare now to navigate this new regulatory era successfully!