Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jun 2009
[Safety of high risk in vitro diagnostic medical devices : international and national measures].
The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) [1] regulates the marketing and post marketing surveillance of IVD in the European Union. In accordance with this regulation, those legally responsible for the IVD product have to report all incidents and corrective measures with IVD to the national competent authority. In Germany, these are the Federal Institute for Drugs and Medical Devices (BfArM) and for high risk products, as specified in Annex II of the Directive 98/79/EC, the Paul Ehrlich Institute (PEI). ⋯ The reporting ratio of the IVD users amounted to 8.5%; in 12 cases (7.1%) PEI was informed via Vigilance Reports from other European competent authorities concerning incidents and recalls with IVD. The experience from 6 years' IVD surveillance showed that the German market surveillance system ensures a high level of safety concerning the in vitro diagnostic medical devices of Annex II list A and B of Directive 98/79/EC. However, the current system can be further optimized.