PARAMETERS FOR CLASSIFICATION OF MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES Basic principles for classification (i) Application of the classification provisions shall be governed by the intended purpose of the device. (ii) If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 78 of 248 (iii) Software, which drives a device or influences the use of a device, falls automatically in the same class. (iv) If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. (v) If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply.