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    New Medical Devices Regulations (MDR) effective; MDR up-dates at SPRINT symposium, 8 February 2019

    To be decisive in health care
    May 2018, the Medical Devices Regulations (MDR) has been changed. So are a number of administrative rules deleted. Ir. Jorrit de Vries, Biomedical Engineering, UMCG, and data scientist at software company Atos Origin, organizes bootcamps about the ins and outs of the updated MDR for researchers and companies. At the SPRINT-symposium, February 2019, Jorrit will give a small bootcamp for SPRINT-partners.
    His principal advice: make sure to be informed in advance about MDR if you have the intention to bring a product to the market in order to be recognized as a medical device. Jorrit: ‘It saves time, disappointment and frustration.’
    A medical device is covered under EU MDR as soon as the innovation or product claims results for the purpose of diagnosis or cure. Jorrit: ‘Or when the product is classified as medical accessory if this accessory is crucial for the function of a device.’ When the device meets MDR standards, the product can claim the
    CE-marking. CE-marking guarantees that the health care product meets the requirements of safety, health, environmental and consumer protection. CE-standard is an unique selling point when bringing innovation to the market.’

    To meet the European CE-standards, health care manufacturers, importers and distributors are instructed to archive in detail how the health care design came about and what choices have been made that have led to the design. A lot of time and work, says Jorrit, but essential: ‘If a product or design causes injury after markt introduction, the documentation can easily show who or what is responsible for the non-functioning of the health product.’

    To make it easier to determine whether a health care product is covered under MDR standards, the Groningen data scientist recently developed a handy checklist on his own. The checklist determines whether it is a medical device or not and provides information about rules to which medical devices must meet in designing life-threatening health care tools such as pacemakers. Jorrit: ‘My checklist offers entrepreneurs the opportunity to evaluate in advance if the health care innovation will be covered under the MDR. The checklist saves you time ánd work. ‘

    SPRINT is a Centre of Research Excellence founded in 2011. It is aimed towards senior citizens regaining or improving their mobility, a goal that is gaining importance because of the ageing populations of many western societies.
    The central within SPRINT are Smart Mobility Devices: smart technical solutions to help especially elderly people to longer maintain their independent mobility. The new devices prevent a decrease in mobility and provides better rehabilitation, preferably within the home environment. In addition SPRINT will develop new prostheses and orthoses.

    The various new technologies will be developed in close cooperation with: Universitair Medisch Centrum Groningen, Rijksuniversiteit GroningenUniversiteit Twente,  and a variety of  companies and institutions.

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