[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). From 2002 to 2007, PEI registered 204 reports concerning incidents with and recalls of IVD medical devices. The majority of incident reports (84.4%) were sent by IVD manufacturers to the 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.
Paul-Ehrlich-Institut, Referat Pharmakovigilanz II, Paul-Ehrlich-Strasse 51-59, 63225, Langen, Deutschland. haljo@pei.de
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Halbauer
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Siekmeier
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M
Funk
D019719:Diagnostic Equipment; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D038622:Internationality; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D018570:Risk Assessment; D017751:Safety Management / Q000331:legislation & jurisprudence*