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No harmonised symbols standard in the EU: error about to be corrected

This article was originally published in Clinica

Executive Summary

A regulatory vacuum now exists in the European standards framework, following the withdrawal of EN 980, the European harmonised symbols standard for medical devices, on 31 January. The standard was due to be replaced by the 2012 version of international standard ISO 15223-1, but the European Commission has not yet harmonised this new standard for use in the EU.