EC Council Directives related to In Vitro Medical Devices, 8/09

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This document contains the cumulative directives of the European Parliament and Council from October 1998 through August, 2009 regarding in vitro diagnostic medical devices.

An in vitro diagnostic medical device is defined as any medical device which is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system intended to be used in vitro (outside the body) for the examination of human specimens, including blood and tissue, for providing information concerning physiological state, pathological state, congenital abnormality, potential recipient compatibility, or therapeutic monitoring.

Section B. Design and Manufacturing Requirements, point 6.1, requires that medical device software must be designed to ensure repeatability, reliability, and performance adequate for intended use.