EU panel approves FDA-like requirements for medical devices (MassDevice)
A European Commission panel approves more stringent regulation of medical devices akin to the FDA's pre-market approval program in the U.S., raising an immediate outcry from the EU's medtech lobby.
A European Commission panel yesterday OK'd more stringent oversight of medical devices in the European Union that would require clinical trials for implants and other Class III devices across the pond.
If enacted, the new regulations would require implants like heart pumps or joint replacements to undergo a process much more li...
