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E-labeling devices in the EU: latest steps suggest it may soon be reality

This article was originally published in Clinica

Executive Summary

E-labeling has been the subject of debate in the EU for over six years, yet companies operating here still have to supply their instructions for use in leaflet form accompanying the device. This is despite heavy lobbying from the industry for a more up-to-date approach. Joachim Wilke, director of regulatory affairs at Medtronic and chair of the Eucomed e-labelling task force reports.

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