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EU’s “timid” eIFU should be extended to more devices, says standards specialist

This article was originally published in Clinica

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Executive Summary

The European Commission’s Regulation 207/2012 on electronic instructions for use (eIFU) for certain device types has been in force for six months. Implemented on 1 March 2013, the Regulation has broad support, but there is nevertheless a sentiment among industry that it is a missed opportunity, with some observers describing it as “timid”.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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