Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
In Directive (98/79/EC) an In Vitro Diagnostic Medical Device (IVD) is defined as any products such as reagent, apparatus, equipments, calibrator, control material, etc. used alone or in combination to examine specimens like blood and tissue extracted from the human body. You can see its live example at www.ilexmedical.com. These devices are helpful in knowing a physiological or pathological state, congenital abnormality, and therapeutic measures of patients.
The IVD Directive (98/79/EC) groups IVDs into four categories. These categories are, in order of increasing perceived risk: • General/Other IVDs: all IVDs other than those covered by Annex II and IVDs for self-testing; • IVDs for Self-Testing: a device intended by the manufacturer to be able to be used by lay persons in a home environment, excluding self-test devices covered in Annex II; • IVDs in Annex II List B of the Directive: which, amongst others, includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self testing for blood sugar; • IVDs in Annex II List A of the Directive: which includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.
