More setbacks for the European device database?
This article was originally published in Clinica
The European Database for Medical Devices (EUDAMED) is unlikely to be operating by the end of 2003, it seems. Although the pilot project is due to start in June this year, regulators and manufacturers are still discussing its content and how to access it, especially as far as vigilance reports are concerned. That is the view of Ekkehard Stosslein, deputy head of the medical devices department and section head of the active medical devices unit at the German Federal Institute for Drugs and Medical Devices (BfArM).