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Directive 2007/47/EC and interpretative document - matters may not be as they seem

This article was originally published in Clinica

Executive Summary

The EU’s medical device directives are due to be amended in seven month’s time when Directive 2007/47/ECtakes effect. The Commission has issued an interpretative document to help manufacturers understand what needs changing and when. However, Elisabethann Wright, partner at the law firm Hogan & Hartson, and colleague Fabien Roy, European regulatory affairs advisor, suggest that matters are still unclear when it comes to the need to update current certificates of conformity and manufacturers would do well to err on the side of caution

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