Cyberbezpieczeństwo wyrobów medycznych w świetle rozporządzenia 2017/745
Cybersecurity of medical devices from the perspective of Regulation no. 2017/745

Summary/Abstract: The specificity of medical devices requires from their manufacturers to put particular emphasis on safety issues related to the devices’ application. At the same time, the development of information technologies, in particular, the Internet of Things, resulted in the wide use of devices communicating over a network, including devices permanently connected to it in the medical field. This phenomenon raises a legitimate question about their security in the context of cybersecurity. This article is an attempt to analyze the issue from the perspective of the provisions of Regulation 2017/745, which enters into force in May 2020. The article considers problems related to the use of medical devices in the light of the risks posed by the Internet, and current legal status concerning the cybersecurity testing of such devices. Furthermore, the analysis covers the scope of the definition of a medical device, whereas particular emphasis is put on prerequisites of the determination of ‘software’ as a stand-alone product. Rules of the classification of medical devices and placing them on the market and, subsequently, regulations concerning the supervision of such devices placed on the market are also critically discussed. The common axis of the analysis is the question on the rules for the validation of safety from the perspective of network threats.

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