EU medtech industry wants notified bodies to be specialized rather than special
This article was originally published in SRA
Executive Summary
The EU medtech industry is calling for notified bodies who audit innovative and high-risk medical devices to specialize in specific medical domains, a measure that goes beyond what have been proposed so far by either the European Commission or European Parliament1. This specialization would address the demands of a sector that spans a wide range of technologies used in a broad scope of medical applications and it carries a variety of potential risks.