Preprint Review Version 1 This version is not peer-reviewed

Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing

Version 1 : Received: 23 April 2019 / Approved: 24 April 2019 / Online: 24 April 2019 (11:17:05 CEST)

How to cite: Ravizza, A.; Di Pietro, L.; Sternini, F.; De Maria, C.; Bignardi, C.; Audenino, A. Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing. Preprints 2019, 2019040265 (doi: 10.20944/preprints201904.0265.v1). Ravizza, A.; Di Pietro, L.; Sternini, F.; De Maria, C.; Bignardi, C.; Audenino, A. Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing. Preprints 2019, 2019040265 (doi: 10.20944/preprints201904.0265.v1).

Abstract

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.

Subject Areas

Medical Device Regulation; wearable medical sensor; medical device; accessory

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