Europeans are left to their own devices

Slick and efficient or opaque and patchy—these are two of the views about the European medical device regulatory system expressed during a recent US Congress debate. But unlike the case with, say, consumer drug advertising, the devices industry argues that conditions are more favourable in Europe.

“European regs are driven by one key goal: innovation,” one industry report suggests.1 And another says that the conditions in Europe favour medical technology companies—they can obtain regulatory approval more quickly, generate revenues faster, and “engage patients and providers in the cycle of innovation to advance their products and services.”2

John Wilkinson, chief executive of Eucomed (a European medical device industry trade association), said in a report: “The current EU regulatory system makes innovative medical technology available to people the fastest in the world while ensuring the highest safety standards.”3

But although the conditions might be more favourable to industry, not everyone agrees that this is the best for patients—and that includes the director of the US Food and Drug Administration’s centre for devices and radiological health, Jeffrey Shuren. Responding to a plastic surgeon’s description of what happens in the EU, he said, “We don’t use our people as guinea pigs in the US.”4

A similar debate is being conducted within the European Commission—and on some levels the Europeans agree. Medical device regulation falls under EU directives, which in turn are implemented by each member state’s national regulator. But the EU claimed earlier this year that there was a need to “adapt the European regulatory framework in order to …