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In Vitro Diagnostic Directive

Any type of Device or Reagent or Instrument or Solution used for the diagnosis of human attributes are covered under this Directive.

The In Vitro Diagnostics are categorized into the below categories,

  • Annex II, List A
  • Annex II, List B
  • Self-testing
  • Devices for performance evaluation
  • All other in-vitro diagnostics

Depending upon the above category the manufacturer has to carry out a suitable conformity assessment according to the relevant IVD Annexes.

Few examples for such type of devices are the following:
[A] Automatic Cell Counter - General
[B] Cholesterol Test - Self-Testing
[C] Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection, HTLV I and II, and hepatitis B, C and D are in List A
[D] Reagents and reagent products, calibrators and control materials, for determining irregular anti-erythrocyte antibodies are in List B
List A & List B devices has to undergo Notified Body Technical File review and site audit.