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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