|Class Ⅰ||1) Sterile (Is)|
2) Measuring (Im)
|Low||Devices that have least interaction with the body||Hospital beds, sterile plasters, weighing scales, thermometers etc.|
|Class Ⅱa||Special Controls required. May need special labelling, obligatory performance standards and post-market supervision||Medium||Devices which are used to check or diagnose the medical conditions or are involved in the exchange of energy with the patient in a curative manner. Generally invasive, but limited to natural orifices. Included in Class Ⅱb if hazardous to patient.||Hearing aid, electrical wheelchairs etc.|
|Class Ⅱb||Special Controls as Class Ⅱa||Medium||Surgically invasive devices that are totally or partially implantable in the body and may modify the proportion of the body fluids||Surgical lasers, ventilators, infusion pumps etc.|
|Class Ⅲ||Pre-market approval is required to establish safety and effectiveness of these devices||High||Support and sustain human life and are of utmost importance to prevent deterioration of human health or which present a possible unreasonable risk of injury or illness. Also includes devices that directly come in contact with the Central Circulatory System or comprise a medicinal product||Neurological and Vascular implants, silicone-gel filled breast implants, replacement heart valves etc.|
Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.
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