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Developers of medical softwares, medical mobile applications,… are you well aware of the impact of the European Medical Devices Regulation on your business ?

20 August 2019 - 9:24

Until recently some medical software, mobile applications and other new technologies applied to healthcare were not considered as medical devices. The situation is going to change in the forthcoming months because of the (relatively) new European Medical Devices Regulations (EMDR), entering into force in May 2020. The main consequence for the digital health start-ups community is that some medical software[1] and medical mobile applications will now be considered as medical devices, requiring for the concerned companies to forecast additional resources and to comply with the regulation. For companies having already their certificate(s), be careful: your device might be « up classed », requiring additional clinical investigation[2]. We urge all of you to take measures regarding these important regulatory changes.

This (up) classification also requires to interact with notified bodies. At the moment there are only 2 notified bodies for the whole Europe that have been audited and designated to certify companies with the new EMDR (BSI and TÜV Süd), meaning that we may expect a bottleneck in the number of demands by med tech companies that will be handled by notified bodies. We have been informed that the best thing to do is to prepare yourself regarding the clinical validation of your medical device and to be as ready as you can.

Please note that being well aware of the important impact that this new regulation might have on small businesses, we, lifetech, are going to take some actions to inform EU authorities about that impact.  Should you be interested to send us your testimony, do not hesitate to contact directly Azèle Mathieu (amathieu@hub.brussels ).

Please find hereafter some relevant resources to help you take the most appropriate measures for your business.

[2] For companies that already have a certificate for their software considered as a medical device, this certified software can be commercialized until the maximal duration of the certificate or May 2024.