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Rules - IVDD

Classification

Directive 98/79/EC divides in vitro diagnostic medical devices into the following four classes:

  • All devices except devices for self-testing and devices in Annex II

  • Devices for self-testing which are not included in Annex II

  • Devices in Annex II, List A

  • Devices in Annex II, List B

List A, Annex II, includes the following devices:

  • Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell

  • Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D

List B, Annex II, includes the following devices:

  • Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd

  • Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies

  • Reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella and toxoplasmosis

  • Reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria

  • Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus and chlamydia

  • Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A and B

  • Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA

  • Reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21

  • The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar

The classification reflects the risks involved in the use of the product based on who the user may be or the consequence if the product fails to perform as intended.






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