“It is a real shame that the EU, with the MDR and the expected AI regulation, is slowing down the emerging healthcare market so much.”
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(Photo: company)
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Düsseldorf Jaroslav Bláha has had enough. The managing director of the Hamburg start-up Cellmatiq has developed a digital medical product for the automated evaluation of jaw x-ray images. The software is already approved – but Bláha still wants to turn his back on the health sector.
The reason for this can be found on 175 pages: the Medical Devices Regulation (MDR). It has been in effect since Thursday, May 26th, with largely no alternative. The MDR brings tightening especially for digital medical devices. For example, most software applications are classified as more risky compared to the old regulation. They now have to be approved by a notified body. So far, a self-assessment was sufficient.
