Against the backdrop of interconnected devices, people, and processes in the Internet of Everything (IoE) an examination of the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE), data protection and cybersecurity rules are carried out with respect to medical devices’ privacy and security. The legal analysis therefore investigates how and to what extent the MDR could cope with the copious challenges of cybersecurity and data protection in the IoE of medical devices. The article sheds light on how the MDR sets a minimal standard of requirements for medical device safety and security. In this respect, an unexpected and complicated regulatory interplay is discussed providing for a well-coordinated approach for digital health technologies. Finally, the article discusses several key points of the proposed EU AI Regulation considering digital health technologies.

在万物互联 (IoE) 中互联设备、人员和流程的背景下，对 MDR （欧洲议会和理事会 2017 年 4 月 5 日关于医疗设备的法规 (EU) 2017/745，修订指令的审查） 2001/83/ EC法规 ( EC ) No 178/2002 和法规 ( EC ) No 1223/2009 以及废除理事会指令 90/385/ EEC和 93/42/ EE )，遵守数据保护和网络安全规则医疗设备的隐私和安全。因此，法律分析研究了MDR如何以及在多大程度上应对医疗设备万物联网中网络安全和数据保护的众多挑战。本文阐明了MDR如何制定医疗器械安全和安保的最低要求标准。在这方面，讨论了意想不到的复杂监管相互作用，为数字医疗技术提供了良好协调的方法。最后，文章讨论了考虑数字健康技术的拟议欧盟人工智能法规的几个要点。