【普瑞研究院】浅析基于人工智能的医疗器械欧盟市场准入
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AI系统定义
高风险AI系统
提案列明高风险AI系统基本要求:
风险管理系统 数据和数据管理
技术文档
建立记录
透明度和向用户提供信息
人为监督
准确性、稳健性和网络安全
提案列明高风险AI系统上市后监管要求:
供应商的上市后监管和上市后监管计划 报告严重事件和事故
欧盟市场AI系统的市场监督和控制
数据访问和文档
基于欧盟国家层面处理存在风险的AI系统程序
防护程序
存在风险的AI系统的符合性
公开违规行为
AI法规提案和现行医疗器械法规的关系
基于AI的医疗器械评估重/难点
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EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes EN ISO 14971 Medical devices - Application of risk management to medical devices EN 62304 Medical device software - Software life cycle processes EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices IEC 82304-1 Health Software Part 1: General requirements for Product Safety EN ISO 31000 Risk management - Guidelines EN ISO/IEC 27000 Information technology — Security techniques — Information security management systems — Overview and vocabulary EN ISO/IEC 27001 Information Technology – Security techniques – Information Security management Systems – Requirements ISO/IEC 80001-1, including IEC/TR 80001-2-xx, Application of Risk Management for IT networks Incorporating Medical Devices ISO/IEC 80001-5-1 Health software and health IT systems safety, effectiveness and security. Part 5-1. Security. Activities in the product life cycle IEC 62443-4-1 Security for industrial automation and control systems. Part 4-1: Secure product development lifecycle requirements IEC 62443-4-2 Security for industrial automation and control systems. Part 4-2: Technical security requirements for IACS components IEC/TR 60601-4-5 Medical Electrical Equipment – Part 4-5. Safety related technical security specifications for medical devices. EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
AI技术在不断的研发,相应的AI法规和标准也在紧锣密鼓的制定中。基于目前的现状,以现行医疗器械法规和标准作为基础,同时尽可能缩小现行医疗器械法规与AI能力相关的安全和性能符合性评估等相关方面的差距。然而在正式的AI法规出台之前,监管机构只能根据case-by-case原则对基于AI的医疗器械审批申请做出决定。
Reference:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
https://eur-lex.europa.eu/eli/reg/2017/746/oj
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