COCIR investigates GHTF tool to help SMEs:
This article was originally published in Clinica
Executive Summary
COCIR, the EU industry association representing manufacturers of electronic and electromedical equipment, is to evaluate manufacturer experience with the standard means of communicating conformity to the essential regulatory requirements as developed by the Global Harmonisation Task Force (GHTF). A number of regulatory authorities have begun pilot programmes accepting the so-called STEDs (Summary Technical Documentation for Demonstration of Conformity to the Essential Principles) and COCIR would like to hear of manufacturers' experiences to date. The aim of its evaluation is to help small and medium-sized manufacturers maximise the potential of the STEDs, since they can potentially significantly reduce the administrative burden of regulatory procedures when exporting to countries that accept them, COCIR says.