Pacemakers and electric toasters have little in common, yet in Europe the same regulatory framework covers both and a growing number of doctors think the system is no longer up to the job. The issue has come to the fore at this year’s annual meeting of the European Society of Cardiology (ESC), which is calling for an overhaul of Europe’s “CE mark” scheme as far as it affects evaluating and approving new medical technology. The push for change in Europe highlights a heated debate on both sides of the Atlantic over how to encourage innovation in often life-saving devices while at the same time controlling risks.
