Classification of in vitro diagnostic medical devices (IVD) describes the category to which an IVD belongs.
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IVDs are grouped into four categories, in order of increasing perceived risk:
- Other/General Device:
all devices except category A or B devices and self-testing devices;
- Device for Self-Testing:
a device intended by the manufacturer to be able to be used by lay persons in a home environment;
- Category B devices:
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;
- Category A devices
of the Directive: which includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.
Contributed by Weber B 2016-02-11