EU medtech association tells firms not to reference amending directive
This article was originally published in RAJ Devices
Executive Summary
European medical technology industry association Eucomed is asking companies not to refer to Directive 2007/47/EC – the amending medical device legislation – in their CE-mark certificates or declarations of conformity1. Reference to the directive has no legal basis before the directive comes fully into effect in March 2010 and would unduly discriminate against products after that date, the association says.
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