In Vitro Devices (IVDs)
In Vitro Devices (IVDs) are typically treated as a subset of medical devices. They provide information for diagnostic, monitoring or compatibility purposes by means of in vitro examination of specimens derived from the human body e.g. blood, tissue, urine and hair.
In most cases IVDs are regulated within the (old) Global Harmonisation Task Force (GHTF) guidance documents, i.e. the IMDRF. This is not the case for all as some countries govern IVDs by separate regulations.
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