Table 1

Risk Classification of Medical Devices in the United States and Europe

United StatesEuropean Union
Class I: low risk of illness or injury, e.g., gauze, toothbrushesClass I: low risk; e.g., sterile dressings, gloves
Class II: moderate risk of illness or injury, e.g., suture, needlesClass IIa: low-medium risk; e.g., surgical blades, suction equipment
Class IIb: medium to high risk; e.g., ventilators, some implants, radiotherapy equipment
Class III: significant risk of illness or injury; e.g., pacemakers, implantable defibrillatorsClass III: high risk; e.g., drug-eluting cardiac stents, pacemakers, implantable defibrillators