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 like the FDA's pre-market approval protocol in the U.S., under control of the European Medicines Agency.
The vote by the EC's Committee for Environment, Public Health & Food Safety drew an immediate outcry from Eucomed, the European medtech lobbying group, which called the proposal "Kafkaesque" and said the regulations would "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," according to a press release.
"No assessment has been made of ...
