MASSDEVICE ON CALL — Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports.
Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA’s more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry.
That’s because EU rules only require that a clinical trial prove a device is no worse than its comparator, while in the U.S. the trial must prove superiority.
"For very established treatments like heart valve treatment, that is very difficult. The U.S. has cut itself off from certain paths of innovation with this policy," Regina Hodits of Wellington Partners, which participated in Middle Peak’s Series A round last year, told the newspaper. "For that reason, it is difficult for medical device start-ups to finance through to market. It has become less interesting for U.S. [venture capital shops] to finance early start-ups."
"We’ve got a steady stream of U.S. companies knocking on our door. Middle Peak Medical was the first one of them. We only do them if we feel the major part of the business will be in Europe like clinical development and the first commercialization," Hodits said.
Last October the European Parliament voted to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the "notified bodies" that govern medical device regulation there.
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