In vitro diagnostic medical device

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In vitro diagnostic medical device

Description

A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

Abbreviation: IVD

Reference: https://www.tga.gov.au/ivd-medical-devices-definitions-links





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It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.
The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD.
Classification of IVDs describes the category to which an IVD belongs. IVDs are grouped into four categories, in order of increasing perceived risk (http://www.ce-marking.com/medical-devices.html#whichclassification):
  • 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.
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