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Device Directives out for comments in EU states

This article was originally published in Clinica

Executive Summary

Several countries are already taking part in a pilot programme European Commission initiative whereby they have put forward their draft national transpositions of the revised Medical Devices Directive and Active Implantable Medical Devices Directive for pre-adoption screening. This revised Directive must be transposed into national law by December 21 2008 and must be fully applied by March 21 2010. The initiative gives the European Commission, member states, industry and even individuals the opportunity to comment, electronically, on the draft laws in an attempt to iron out any discrepancies. This, the Commission says should obviate "costly and controversial infringement proceedings" which could otherwise only be launched after the texts had become law. The other great advantage of this pre-adoption screening procedure is that is "spreads the word" on best practices, which then become a model for regulatory initiatives in other countries.

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