Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until end 2007
Abstract The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and post market surveillance of IVD in the European Economic Area.In cases of issues and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA).In Germany, the Federal Institute for Drugs and