Table 4.

MDSW classification under the IVDR.

Type of software/intended purposed	Regulation
Software intended to be installed on a fully automated enzyme-linked immunosorbent assay (ELISA) analyzer, and intended to determine the Human HbA1c concentration in serum from the results obtained with a Human HbA1c ELISA, intended to screen for and diagnose diabetes and monitor diabetic patients	Class C per Rule 3 (k)
Software within a PAP stain automated cervical cytology screening system, intended to classify the PAP cervical smear as either normal or suspicious	Class C per Rule 3 (h)
Software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma	Class D per Rule 1
Software that uses maternal parameters such as age, concentration of serum markers and information obtained through fetal ultrasound examination for evaluating the risk of trisomy 21	Class C per Rule 3 (1)