미국과 유럽의 AI 기반 의료기기 소프트웨어 규제제도 고찰과 국내 허가현황 분석

초록

Medical devices incorporating artificial intelligence (AI) technology have been actively developed, but they may pose risks to patient safety by providing misleading information. This study aims to review the status of AI-enabled medical devices approved in Korea and the regulatory frameworks of the United States and the European Union governing the devices to draw key lessons. To assess the current status of software as a medical device (SaMD) approved in Korea, a search for “software” was conducted on the Medical Device Safety Information website (mfds.go.kr) of the Ministry of Food and Drug Safety. The Food and Drug Administration employs a risk assessment approach to oversee all medical devices, including SaMD. The European Medicines Agency introduced the Artificial Intelligence Act to establish risk classification, transparency requirements, and human oversight provisions. As of September 1, 2024, a total of 1,513 software-based medical devices have been approved in Korea, of which only a small number are AI-enabled devices. The U.S. and the E.U. share concerns regarding transparency issues and potential risks associated with AI-enabled medical devices, and both regions follow a risk-based regulatory approach. As the number of AI-enabled medical devices is expected to grow both in Korea and internationally, a robust risk assessment approach should be regarded as a fundamental component of the regulatory framework to ensure patient safety.

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