EU medtech wrapped in red tape
Last week, the European Parliament issued a resolution calling for urgent revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), frameworks originally designed to raise safety and performance standards while fostering healthtech innovation.
But here's the problem: the execution is tangled up in complexity, leaving startups and the broader industry navigating a tough regulatory maze. And with no swift fix in sight, the EU risks undermining its healthtech ambitions.
What's going wrong? Lengthy certification timelines and convoluted procedures are creating roadblocks, especially for startups. These delays aren’t just bureaucratic headaches—they’re hitting patient access hard, limiting the availability of life-saving devices, and exacerbating disparities in healthcare access across Member States. The new resolution calls this out directly, spotlighting the urgent need for a fairer, faster approach that keeps innovation within the EU.
This push for change is backed by the recent Draghi Report, which paints a worrisome picture of regulatory bottlenecks leading to supply gaps, device withdrawals from the EU market, and lost competitive ground. In short, Europe’s healthtech sector is taking some serious hits—ones that could undermine its position in the global market if left unaddressed.
This would be a major blow to its burgeoning healthtech startup scene which has been at the forefront of innovations that could help to relieve the strain on overwhelmed medical staff.
For example, our Head of Media, Andrii Degeler, recently interviewed Diana van Stijn, CEO of Lapsi Health, about their innovative 'smart stethoscope.' Have a listen to the interview and Andrii's heartbeat in our latest podcast episode:
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