Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Oct 2007
[Safety of in-vitro diagnostics used in transfusion medicine. Experience of the BfArM until end 2005].
The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVD) stipulates the marketing and post marketing surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions related to IVD, manufacturers have to inform the responsible Competent Authorities. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible Competent Authority for most IVD. ⋯ In consequence, corrective actions were performed in the large majority of cases (n=37; 77.1%). These included customer information, product recalls, changes in production or quality management and software upgrades (the latter predominantly in cases of failures of analysing instruments). Our data suggest that the governmental system for marketing surveillance is an established tool to ensure product safety for IVD used in transfusion medicine.