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EU medtech reform proposals 'don't go far enough'

This article was originally published in SRA

Executive Summary

The European Commission’s recently published plans to strengthen the current regulatory framework for medical devices do not go far enough, a group of four European organisations representing among other things health professionals, health insurance bodies and social security systems and patients groups is arguing1. The proposals are not sufficient to safeguard patients from potentially harmful devices, they say, and they call for a centralised pre-market approval system where safety, efficacy and a positive risk-benefit balance must be proven through high-quality clinical investigations.

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