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IVD MEDICAL DEVICES

Which category does an In Vitro Diagnostic Medical Device (IVD) falls into?

The IVD Directive (98/79/EC) groups IVDs into four categories.

  • All general devices except Annex II and self-testing devices.
  • Device for Self-Testing which are not listed in Annex II and 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.
  • Annex II list B devices which amongst others include reagents and products for rubella, oxoplasmosis and phenylketonuria as well as devices for self testing for blood sugar.
  • List A, Annex II Devices which includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.

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