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Review of EU New Approach set for 2006

This article was originally published in Clinica

Executive Summary

The European Commission is celebrating 20 years of the New Approach to technical harmonisation and standards, the basis on which the EU medical device directives have been drafted. It has used the occasion to highlight the popularity of the New Approach, which, it said, "revolutionised European product legislation by making EU-wide harmonisation possible based on the simple condition that the producer guarantees that its products are safe".

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