Expert Calls Europe's Regulatory Frame a SmokescreenExpert Calls Europe's Regulatory Frame a Smokescreen

In an interview with BBC, Richard Horton, MD, editor of the Lancet medical journal lambasted the EU regulatory process for medical devices, citing the recent scuffle over the quality of silicone implants.

Horton's comments include a call out of the quality of hip replacements, heart valve replacements, in addition to silicone implants. " We have a smokescreen of device regulation, which is putting patients at risk. We do not have adequate clinical trials to prove the safety and effectiveness of many devices."

But it is not just manufacturers who are under Horton's scrutiny, "Private sector providers of healthcare are are walking away from their responsibility to patients.

The upshot? Things are about to change in the EU.

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