IVD Medical Device Risk Classification

Classification
What are the medical device risk classes in place in Europe?

DIRECTIVE 98/79/EC
(18 June 2009)

ANNEX II
LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)

List A

  • 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

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