Impact of medical device regulation on developing health behavior change support systems

Abstract

<div lang="en" class="abs"><p class="abs_header">Abstract</p><p>The enforcement of the Medical Devices Regulation (MDR) began in the European Union (EU) in May 2021. Under MDR, software and information systems may be considered as medical devices. Behaviour Change Support Systems (BCSS) are information and communication technologies aimed at helping their users to achieve behaviour change targets. Designers, developers, and researchers of health BCSS (hBCSS) need to understand the impact of this new regulation on the development of such systems as the regulation influences both design and development in a variety of ways. Furthermore, myriads of health BCSS have been developed previously in the medical, fitness, and wellbeing domains, and a substantial number of them may require qualification, classification, or reclassification as medical devices under the new regulation. However, the regulation process is complex and requires knowledge and expertise which many manufacturers do not have in-house. Depending on the context and classification, the costs may suddenly ramp up and become too much for smaller developers, and thus they should be carefully assessed. In this paper, we discuss the regulation from the point of view of hBCSS developers. We look at the regulatory process and highlight key issues for developers of hBCSS. Particular attention is given to the classification and design requirements most likely to pose immediate challenges to developers. In addition, we discuss the costs associated with MDR which are difficult to estimate without previous experience.</p></div>