Eudamed will not improve safety without real harmonisation
This article was originally published in Clinica
Executive Summary
The European Commission has finally made use of the European Union’s medical devices database (Eudamed) obligatory from May 2011 (see www.clinica.co.uk, 19 April 2010: European Regulatory Database to become mandatory next year). The database itself has been a long time in the making, having been first conceived of in 1998, but it is finally here and one of its major aims is to make the use of medical devices safer. This means that it will facilitate the use of the Medical Device Vigilance System (MDVS), by helping member states to communicate about adverse incidents involving devices.