PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic principles for classification of in vitro diagnostic medical devices (a) Application of the classification provisions shall be governed by the intended purpose of the devices. (b) 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. (c) Software, which drives a device or influences the use of a device, falls automatically in the same class. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 87 of 248 (d) Standalone software, which are not incorporated into the medical device itself and provide an analysis based on the results from the analyser, shall be classified into the same category that of the in vitro diagnostic medical device where it controls or influences the intended output of a separate in vitro diagnostic medical device. (e) Subject to the clause (c) and (d), software that is not incorporated in an in vitro diagnostic medical device, shall be classified using the classification provisions as specified in paragraph 2. (f) Calibrators intended to be used with a reagent should be treated in the same class as the in vitro diagnostic medical device reagent. (g) If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the stringent rules resulting in the higher classification shall apply.