MASSDEVICE ON CALL — European medical device makers are fighting against the swell of support for new laws that would tighten regulatory oversight of healthcare technologies.
Lawmakers and healthcare officials have backed proposed regulation that would create within the E.U. regulatory body an agency similar to the FDA that would require more from new devices looking to sell on local markets.
Last week a European Commission panel backed the new proposals, about 2 years in the making, and members have Parliament have begun voicing their support as well. The regulations would require full parliamentary confirmation before taking effect, and industry advocates are interested in preventing that from happening.
"The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers," told Reuters.
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