Moves to oust custom-made devices from EU database
This article was originally published in Clinica
Executive Summary
There will no longer be a requirement for manufacturers to register their custom-made medical devices on the European medical devices database, EUDAMED. At least, that is if the proposal made by the European Commission to industry, member state authorities and notified bodies at the October 19-20 Medical Device Experts Group (MDEG) meeting goes ahead.