Recast will seek to better define scope of EU medtech directives
This article was originally published in RAJ Devices
Executive Summary
One of the key aims of the European Commission in the recast of the medical device directives it is working on is to ensure that there is better clarity than there is at present about which products are and are not regulated under the directives. Areas of focus include products on the borderline with other directives, as well as implantables or other invasive devices without a medical purpose.