In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

近年来，人工智能（AI）在医疗领域的应用越来越受到关注。由于其令人印象深刻的优势，人工智能系统为使用这些系统升级其产品的医疗设备制造商提供了良好的前景。这种基于人工智能的医疗设备已经受到医疗设备法规 745/2017 范围内的部分监管。然而，在欧盟委员会发布的人工智能监管提案之后，这些设备的监管环境发生了部分变化。本文旨在阐明欧盟委员会的这一监管干预对人工智能的使用和营销路径产生的影响- 基于医疗设备。