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

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

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… 

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