What is an IVD?
The EU In Vitro Diagnostic Regulation (IVDR) gives the following definition of a medical device for in vitro diagnostics (IVD):
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
The IVDR also includes specimen receptacles in its definition.
Companion Diagnostics (CDx)
Devices for companion diagnostics are a special kind of IVD. The IVDR defines companion diagnostics as:
devices that are essential for the safe and effective use of corresponding medicinal products to identify:
patients who are most likely to benefit from the corresponding medicinal product, before and/or during treatment;
patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal products, before and/or during treatment.