Niemiec Emilia
Medical Ethics Division, Department of Clinical Sciences, Lund University, Sweden.
Digit Health. 2022 Mar 30;8:20552076221089079. doi: 10.1177/20552076221089079. eCollection 2022 Jan-Dec.
Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe. Recently, the Medical Device Regulation, which aims to set high standards of safety and quality, has become applicable in the European Union. The aim of this article is to discuss whether, and how, the Medical Device Regulation will help improve the safety and performance of medical artificial intelligence devices entering the market. The Medical Device Regulation introduces new rules for risk classification of the devices, which will result in more devices subjected to a higher degree of scrutiny before entering the market; more stringent requirements on clinical evaluation, including the requirement for appraisal of clinical data; new requirements for post-market surveillance, which may help spot early on any new, unexpected side effects and risks of the devices; and requirements for notified bodies, including for expertise of the personnel and consideration of relevant best practice documents. The guidance of the Medical Device Coordination Group on clinical evaluation of medical device software and the MEDDEV2.7 guideline on clinical evaluation also attend to some of the problems identified in studies on medical artificial intelligence devices. The Medical Device Regulation will likely help improve the safety and performance of the medical artificial intelligence devices on the European market. The impact of the Regulation, however, is also dependent on its adequate enforcement by the European Union member states.
人们对医疗人工智能设备的性能证据质量表示担忧，包括已在美国和欧洲上市的设备。最近，旨在设定高标准安全和质量的《医疗器械法规》已在欧盟适用。本文旨在探讨《医疗器械法规》是否以及如何有助于提高进入市场的医疗人工智能设备的安全性和性能。《医疗器械法规》为设备的风险分类引入了新规则，这将导致更多设备在进入市场前受到更高程度的审查；对临床评估提出了更严格的要求，包括对临床数据评估的要求；对上市后监测提出了新要求，这可能有助于尽早发现设备的任何新的、意外的副作用和风险；以及对公告机构的要求，包括对人员专业知识的要求和对相关最佳实践文件的考虑。医疗器械协调小组关于医疗器械软件临床评估的指南以及MEDDEV2.7临床评估指南也关注了医疗人工智能设备研究中发现的一些问题。《医疗器械法规》可能有助于提高欧洲市场上医疗人工智能设备的安全性和性能。然而，该法规的影响还取决于欧盟成员国对其的充分执行。
