New Delhi: In a move to streamline regulatory oversight of medical devices, the Central Drugs Standard Control Organisation (CDSCO) has released the official risk classification list for medical devices used in interventional radiology.The notification, issued on November 26, 2025, follows the draft list published earlier this year and has been finalized under the authority granted by the Medical Devices Rules (MDR), 2017.According to the notice issued, the classification has been carried out under sub-rule (3) of Rule 4 of the MDR 2017, enabling the regulator to categorize devices based on their intended use and associated risk level.Also Read: Abbott begins medical device correction for certain glucose monitors in USAs per the Medical Device Rule, 2017, medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, into the following classes:—(i) low risk-Class A;(ii) low moderate risk-Class B;(iii) moderate high risk-Class C;(iv) high risk-Class DThe finalized list, provided in Appendix A of the notice, outlines the risk classification for various interventional radiology devices and it is subject to the following:1. General intended use given against each of the devices is for guidance of the applicants who intend to furnish applications for manufacturing/import of medical devices under the Medical Devices Rules, 2017. However, a device may have a specified intended use as specified by its manufacturer.2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.Classification of Medical Devices Pertaining to Interventional RadiologyS. No.Device nameIntended useRisk Classification1Angiographic x- ray systemAn angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium.Class C2Angiography contrast medium injection system, battery-poweredA battery-powered assembly of devices intended to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities).Class C3Angiography contrast medium injection system, line-powered, mobile/stationaryAn assembly of devices intended to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It may additionally synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator.Class C4Automatic-aperture- control diagnostic x-ray system collimatorA standard, diagnostic x-ray beam-limiting and shaping device intended to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas by automatically adjusting the shutters so that the x-ray beam shape matches the size of the film cassette in the holder.Class B5Axial length measuring ultrasound systemAn ophthalmic device intended to measure axial length of the eye (distance along the axis of the eye between the anterior corneal surface and the anterior retinal surface) using ultrasound technology.Class B6Basic/General-purpose diagnostic x-ray system, mobile/stationary/ portableAn assembly of devices that comprise an analogue general- purpose diagnostic x-ray system used in a variety of routine x-ray imaging applications using analogue or analogue-to- digital technologies. It may be used for bedside imaging and for interventional and intraoperative imaging.Class C7Bladder ultrasound imaging transducerAn ultrasound imaging transducer assembly specifically intended to be positioned within the bladder either manually or under endoscopic guidance that steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically.Class B8Bladder volume ultrasound imaging systemAn assembly of devices intended for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).Class B9Blood flowmeter catheter, DopplerA flexible tube intended to be inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle).Class C10Body-orifice ultrasound imaging transducer coverA sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g.,…

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