Notified bodies: are they fit for purpose?

Slick and efficient or opaque and patchy—these are two of the views about the European medical device regulatory system expressed during a US Congress debate last year.1 Over the past few years there has been mounting concern about Europe’s system for approving high risk medical devices such as hip replacements, cardiac pacemakers, and other implants.

In the United States, the Food and Drug Administration (FDA) assesses whether companies should be able to market a device. However, in the European Union the task of determining whether a medical device is safe and performs according to certain standards is …