‘No More Questions’ On Scrutiny As EU Talks Set To Give Notified Bodies Yet More Responsibility
This article was originally published in Clinica
Executive Summary
While it is premature to speak of agreement, it seems that the three parties involved in negotiating the future EU medtech regulations have reached a point where there are “no outstanding questions any more” on one of the biggest sticking points – the scrutiny of high-risk medical devices. However, Clinica understands that this is not yet the case for scrutiny of in vitro diagnostics.