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European standards and the In Vitro Diagnostic Directive: current status
1European Diagnostic Manufacturers Association, Brussels, Belgium.
Medical Device Technology
|June 6, 1996
Abstract:
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.