Weight of German vigilance reports: need for EU alignment
This article was originally published in Clinica
Executive Summary
A huge debate is brewing among the medical device regulatory authorities in the EU over what information should be shared between them under the medical device directives. At the moment there is an absurd imbalance in the amount of reporting, with Germany racing ahead and proud of its record of reports which leaves other countries looking as if they have just left the starting line. Some redressing of the global reporting rules has occurred; will the EU now follow? Amanda Maxwell reports