Decoding the Classification of Medical Devices

Regulatory controls are intended to protect and safeguard the health and safety of patients. These controls were meant to ensure that manufacturers of medical devices adhere to specified procedures the product realization process which consist of designing, manufacturing and marketing. The higher degree of risk will result in more stringent regulatory control, taking account of the benefits offered by use of the device. Therefore, there will a necessity to classify medical devices based on their risk to patients, users and other persons.

The risk presented by a particular device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture and use. The risk presented by a device also depends, in part, on its intended user, its mode of operation, and/or technologies. In general, the classification rules are intended to accommodate new technologies.

The Classification of IVD Medical Device is based on the following criteria the intended use of the device as specified by the manufacturer the importance of the information to the diagnosis the impact of the result (true or false) to the individual and/or to public health.
Kindly refer to figure 1