Classification

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MitoPedia

Classification

Description

Classification of in vitro diagnostic medical devices (IVD) describes the category to which an IVD belongs.


Reference: http://www.ce-marking.com/medical-devices.html#whichclassification


MitoPedia concepts: MitoFit Quality Control System 






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