Medical Device Link.

MATERIALS

Medical devices are classified according to the level of control that is necessary to ensure the safety and effectiveness of the device during its intended use. The United States Food and Drug Administration and the European Medical Device Directive 93/42/EEC have defined three classes of medical devices: Classes I, II and III, with Class III requiring the greatest control. To obtain clearance or approval to market and sell a medical device, the manufacturer must provide the Notified Body with all information necessary for proper assessment of the device’s conformity to specified requirements.