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EU tightens up regulations in year of unprecedented change

This article was originally published in Clinica

Executive Summary

After nearly a decade of criticism over weaknesses in the EU medical device regulatory system, mainly focused on inadequacies among notified bodies, 2002 at last saw the European Commission and national regulators take a good, hard look at their own shortcomings, writes Amanda Maxwell. The result was a tightening of controls on a scale that has not been seen before and which, some argue, goes against the basic philosophies that underpin the medical device directives

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