INTERVIEW: Get your EU clinical evaluation report shipshape or get your products pulled
This article was originally published in Clinica
Executive Summary
It may still be several years before the new EU regulation for medical devices come into full force, but if the medtech industry does not keep up to date with current changes to clinical evaluation requirements, it could well find its products pulled from the market. Amanda Maxwell spoke with Sarah Sorrel, founder and president of MedPass International, to find out what manufacturers need to know to ensure they do not fall on the wrong side of the regulators