Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.

During the next phase of COVID-19 outbreak, mobile applications could be the most used and proposed technical solution for monitoring and tracking, by acquiring data from subgroups of the population. A possible problem could be data fragmentation, which could lead to three harmful effects: i) data could not cover the minimum percentage of the people for monitoring efficacy, ii) it could be heavily biased due to different data collection policies, and iii) the app could not monitor subjects moving across different zones or countries. A common approach could solve these problems, defining requirements for the selection of observed data and technical specifications for the complete interoperability between different solutions. This work aims to integrate the international framework of requirements in order to mitigate the known issues and to suggest a method for clinical data collection that ensures to researchers and public health institution significant and reliable data. First, we propose to identify which data is relevant for COVID-19 monitoring through literature and guidelines review. Then we analysed how the currently available guidelines for COVID-19 monitoring applications drafted by European Union and World Health Organization face the issues listed before. Eventually we proposed the first draft of integration of current guidelines.

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Background: medical devices are designed, tested and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. Material and methods: the purpose of this paper is to take into consideration the upcoming EU Medical Device Regulation 2017/245 and the current and future IEC and ISO standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971 and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. Results: current and future regulatory restrictions are described, and an integrated method for design planning, validation and clinical testing is described Discussion: application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to the time-to-market of the device.