EU Commission to better define medtech directive scope: borderline and aesthetic issues
This article was originally published in Clinica
Executive Summary
One of the European Commission’s key aims in the recast of the medical device directives is to ensure that there is much greater clarity about which products are regulated under the directives and which product areas do not come under their scope. Areas focus include products on the borderline with other directives, as well as implantables or other invasive devices without a medical purpose.