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EU's 'timid' eIFU should cover more devices, says standards expert

This article was originally published in SRA

Executive Summary

The European Commission’s Regulation 207/2012 on electronic instructions for use (eIFU) for certain medical device types has been in force for around six months1,2. Implemented on 1 March, 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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