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Medical Device Regulation

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FDA embraces medical innovation in 2017

Posted on November 27, 2017

On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to…

European Union’s new medical device regulations come into force

Posted on May 25, 2017

Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical…

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