European standards and the In Vitro Diagnostic Directive: current status.
The role of harmonized standards to support the proposed In Vitro Diagnostic Directive is examined in this article. EDMA is undertaking a number of activities to aid the standards work. These projects include guidelines on how to construct a technical file and how to conduct risk analysis. These and other initiatives will ensure the active participation of the IVD industry in the formulation of the standards.
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European Diagnostic Manufacturers Association, Brussels, Belgium.
D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D017053:Infection Control; D011786:Quality Control; D012015:Reference Standards