Picking the right agency to review device/drug combinations in the EU
This article was originally published in SRA
Executive Summary
Manufacturers of device/drug combinations in the EU can choose which competent authority reviews the drug element of their product. The drugs world, however, can be a mystery for those with a devices background. So where do these companies start? In theory, the EU is their oyster. In practice, though, only a few authorities seem to offer the service required. Amanda Maxwell reports.