Danes review UK/French proposal on CNS (central nervous system) devices:
This article was originally published in Clinica
Executive Summary
The Danish medical device industry association, Medicoindustrien, is seeking the views of its members on one of the controversial proposals put forward by the French and UK authorities which are intended to tighten the requirements of the Medical Devices Directive (MDD). It is asking for comments on the UK and French proposal that invasive devices intended for use in the central nervous system for less than 60 minutes be placed in class III, the highest risk class, in future. At present, Rule 6 of the MDD generally places invasive devices for transient use in class IIa.