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"Conditional CE marking" - a new concept in device innovation?

This article was originally published in RAJ Devices

Executive Summary

The European Commission's public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) contains a section on "conditional CE marking" that has caught the attention of European medtech industry association Eucomed1. John Brennan, Eucomed's director of technical & regulatory affairs, told RAJ Devices that, although IVDs did not fall within Eucomed's scope per se, the trade association would be analysing this particular issue because "it could be an interesting vehicle for innovation in Europe".

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