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John O’Dea just isn’t pleased. New laws by Brussels have elevated sixfold the price of the serial medtech entrepreneur having his new medical system permitted and able to launch in Europe.

O’Dea’s firm, Palliare, has created a tool known as Eva15 that helps surgeons to inflate areas of the physique throughout an endoscopy. It lately paid €90,000 in charges to the Irish regulator of medical units, in contrast with the €15,000 he forked out simply two years beforehand.

For a start-up it’s a massive value, however it’s not the one problem arising from the brand new European Medical Devices Regulation that was handed in May 2017 and got here into pressure final yr.

The new legal guidelines have been put in place to make merchandise safer for sufferers

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#Medtech #bosses #discover #European #laws #bitter #capsule #Ireland

By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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