Fit for purpose? European Commission fields questions on device notified bodies database
This article was originally published in SRA
Executive Summary
The tough new requirements for medical device notified bodies in the EU and the harsher environment in which they operate mean that not all of them are managing to stay the course. But when it comes to medtech companies finding out which of these testing and certification bodies for medical devices and IVDs are still operating and which are not, there is no easy way.