International Journal of Medicine and Data
International Journal of Medicine and Data. 2022; 6: (5) ; 10.12208/j.ijmd.20220205 .
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国家药品监督管理局医疗器械技术审评中心 北京
*通讯作者： 刘英慧,单位：国家药品监督管理局医疗器械技术审评中心 北京；
基于人工智能和机器学习（Artificial Intelligence and Machine Learning，AI/ML）医疗器械近年来发展迅速。然而，我们对基于AI/ML的医疗器械是如何在欧洲获得批准的情况知之甚少。新的欧洲医疗器械法规（European Medical Device Regulation，EU MDR）的发布实施日期为2021年5月26日，该法规提出了在人工智能软件产品应用于临床实践之前需要满足的相关要求。欧盟在该领域的发展尚处于起步阶段，自2015年以来，欧盟有80多种AI产品上市，临床试验和同品种临床数据分析是主要上市途径，本文从欧盟法规对人工智能医疗器械产品上市的相关要求进行阐述，总结前沿监管思路与方法，以期对我国人工智能产品的监督与管理提供参考。
Medical devices based on artificial intelligence and machine learning (AI /ML) have developed rapidly in recent years. However, we know little about how Al /ML based medical devices are approved in Europe. The new European medical device regulation (EU MDR) is issued and implemented on May 26, 2021. The regulation puts forward the relevant requirements to be met before the application of artificial intelligence software products in clinical practice. The development of EU in this field is still in its infancy. Since 2015, more than 80 AI products have been launched in the EU. Clinical trials and clinical data analysis of the same variety are the main ways to launch AI products. This paper expounds the relevant requirements of EU regulations on the launch of AI medical devices, and summarizes the frontier regulatory ideas and methods, In order to provide reference for the supervision and management of artificial intelligence products in China.
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