Qualified Person Eliminated Plus Other Surprises In EU Reg Reform
This article was originally published in Clinica
Executive Summary
The end to the concept of a qualified person, fewer pillars in the Eudamed medical device database than were expected, a likely 25% reduction in the number of notified bodies by the end of this year and the disappearance of own-brand labelling. These are among the details of the changes to the European Commission’s original draft proposals for a new Medical Device Regulation and IVD Regulation that are starting to emerge, reports Amanda Maxwell