August 3, 2023

Start-ups left hanging in EU medical device regulation snarl-up

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Delays in getting the CE mark for medical devices are stretching the resources of European start-ups and forcing some to turn their attention to the US

Europe is facing a medical device gridlock as companies wait to have old and new products certified under the recently enforced Medical Device Regulation. The European Council has extended deadlines so that existing devices will not disappear from the market, but the ever-lengthening wait for certification is crippling start-ups that need approval in order to attract investors and move their innovative new devices to the market.

“The slow process of medical device certification in Europe is having a significant impact not only on us, but on all innovative healthtech and biotech start-ups trying to quickly establish themselves in a dynamic, competitive market,” said Daniel Kvak, co-founder and chief executive of Prague-based Carebot, which is developing an artificial intelligence system that helps surgeons analyse chest X-rays for signs of cancer.

There are also concerns that this situation puts European start-ups at a disadvantage relative to international competitors. “Similar start-ups from Africa or Asia do not have this obstacle,” said Alexis Fourlis, the co-founder and chief executive of Greek start-up EMMA, which is developing a hospital triage support system.

Read the full article here.

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