Medical devices may be placed on the Community market only if they meet the essential requirements of the relevant European directive, have undergone an appropriate conformity assessment procedure and have been issued with a declaration of conformity. By affixing the CE mark, the manufacturer declares that the medical device meets the relevant requirements.
The manufacturer is solely responsible for the medical device as well as its design and properties. He defines the intended purpose and describes the primary mode of action of the device. For medical devices with higher risk classes, a notified body must be involved.