The purpose of this paper is to define and evaluate a classification category for contrast-enhanced (CE) MR imaging of the breast based on the BI-RADS mammographic categories of the American College of Radiology. Using five evaluation criteria for MR findings (initial signal increase, post-initial signal behavior, shape, border, and contrast material distribution within enhancing tumors) 522 patients (1031 breasts) were analyzed. Scores were given from 0 to 8 points and classified into five categories (group I: 0 points, negative; group II: 1-2 points, benign; group III: 3 points, probably benign; group IV: 4-5 points, suspicious abnormality; group V: 6-8 points, highly suspicious for malignancy) to 265 focal hypervascularized breast lesions in 244 breasts (patient group A). These findings were correlated with histology or follow-up. Additionally, this classification was correlated to the contrast medium uptake within the parenchyma of the remaining 787 breasts without any focal lesion (patient group B). Two hundred sixty-five hypervascularized lesions in 238 patients (244 breasts, patient group A) were classified into group I: 0%; group II: 27.3%; group III: 22.3%; group IV: 18.6%; and group V: 31.8%. Histology revealed 115 benign and 134 malignant tumors in these groups. Sixteen benign lesions were controlled by follow-up. Sensitivity for the detection of malignancy using the presented multifactorial MRM classification was 92%, and specificity was 92%. Excluding cases of ductal carcinoma in situ specificity increased to 95%. Seven hundred eighty-seven breasts without any focal hypervascularized lesion (patient group B) were classified into groups I or II. Follow-up ( n=771) or histology ( n=14) confirmed the diagnosis in 785 of these breasts. Histopathology revealed, however, malignant tumors in the remaining two cases. The classification of lesions based on a multifactorial analysis is very helpful in the interpretation of CE MRI of the breast. The evaluation of all diagnostic imaging modalities, however, is essential in determining the correct diagnosis and/or in deciding on the appropriate therapeutic procedure.