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Table 1 Medical Device Bureau classification of medical devices

From: Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

MDB Class Risk Examples
Class I Lowest risk Surgical instruments, culture media
Class II Low risk Contact lenses, epidural catheters, pregnancy test kits, surgical gloves, ultrasound scanner
Class III Moderate risk Orthopaedic implants, glucose monitors, dental implants, haemodialysis systems
Class IV High risk HIV test kits, pacemakers, angiographic catheters