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Did they really say that?

This article was originally published in Clinica

Executive Summary

The quotes tell the story. During the last year, many key players in the industry spoke their minds over issues such as the CE mark, user fees, device reuse and FDA reform. Clinica looks back at some of the most controversial and succinct observations.The CE mark for devices "seems only to mean that the person that plugs it in will not get an electric shock". A remark few in the device industry would agree with but it more than exemplified the debate in Europe over the value of the CE mark which continued throughout 1999. It came from Professor Martin Buxton, director of the health economics research group at London's Brunel University, at a meeting on the UK's new National Institute of Clinical Excellence.

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