www.fdanews.com/articles/138930-eu-should-tighten-premarket-device-regs-belgian-org-says
EU Should Tighten Premarket Device Regs, Belgian Org Says
August 3, 2011
EU device regulations should be more in line with the U.S., with randomized controlled trials considered the highest standard to document efficacy and safety, a Belgian federal institution is urging.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor