Feature Medical Device Regulation

Notified bodies: are they fit for purpose?

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7177 (Published 24 October 2012) Cite this as: BMJ 2012;345:e7177
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

Deborah Cohen explains how medical devices get on to the European market

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 …

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