Table 1 Responsibilities of BfArM and PEI regarding IVD listed in Annex II of Directive 98/79/EC [1–4].

Products for immune hematological testing and tissue typing:

   Blood groups of the AB0 system^{1, 2}

   Blood groups of the Rhesus system (C, c, D, E, e)^{1, 2}

   Blood groups of the Kell system^{1, 2}

   Blood groups of the Duffy and the Kidd system^{1, 2}

   Irregular anti-erythrocyte antibodies^{1, 2}

   Markers for HLA³ typing, markers DR, A and B^{1, 2}

Products for infection testing:

   Markers of HIV⁴ infection (HIV-1 and HIV-2)^{1, 2}

   HTLV-I⁵ and HTLV-II^{1, 2}

   Hepatitis B, C and D1, 2

   Congenital infection with rubella^{1, 2}

   Congenital infection with toxoplasma^{1, 2}

   CMV^{1, 2, 6}

   Chlamydia^{1, 2}

Other products:

   Tumor marker PSA^{1, 7}

   Hereditary diseases phenylketonuria and Down syndrome (trisomy 21, including software)¹

Products for self testing:

   Systems for measurement of blood glucose¹