Regulation 2024/1689 (AI Act) imposes a new framework for artificial intelligence, with risk-based classification and a key deadline of 2 August 2027 for high-risk medical devices. Key points and steps to prepare.
Published on 12 July, 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-𝗯𝗮𝘀𝗲𝗱 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: AI systems are now classified into four risk levels, ranging from unacceptable risk to minimal risk. Those at high risk, such as certain Medical Devices (MDs), will require specific measures including human oversight and rigorous technical standards.
• 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: For high-risk systems, the implementation of a Quality Management System (QMS) compliant in particular with ISO 42001, the development of technical documentation and obtaining a CE marking are required.
• 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗱𝗲𝗮𝗱𝗹𝗶𝗻𝗲: Mark 𝟮 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟬𝟮𝟳 in your calendars, a crucial date for the compliance of 𝗵𝗶𝗴𝗵-𝗿𝗶𝘀𝗸 𝗠𝗗𝘀 with the AI Act.
𝗡𝗲𝘅𝘁 𝘀𝘁𝗲𝗽𝘀 𝘁𝗼 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 ➡️
𝟭. 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝘁𝗲𝘅𝘁 𝗼𝗳 𝘁𝗵𝗲 𝗔𝗜 𝗔𝗰𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 to understand the implications for your organisation.
𝟮. 𝗔𝘀𝘀𝗲𝘀𝘀 𝘆𝗼𝘂𝗿 𝗔𝗜 𝘀𝘆𝘀𝘁𝗲𝗺𝘀 to determine their risk classification under the new regulation.
𝟯. 𝗗𝗲𝘃𝗲𝗹𝗼𝗽 𝗮 𝗴𝗹𝗼𝗯𝗮𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆 integrating the General Data Protection Regulation (GDPR), the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to ensure complete integration of regulatory standards.
𝟰. 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵 𝗮 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝘆 that can assess the AI part of your systems.
𝟱. 𝗔𝗱𝗮𝗽𝘁 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 to meet the specific requirements of your AI systems.
Get ready now to successfully navigate this new regulatory era!
