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
Medical Device Regulation
European Union’s new medical device regulations come into force
Posted on
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…