Purpose of medical devices. Each of thePurpose of medical devices. Each of the

Purpose of regulatory body and medical devices:Around the world, millions of patients depend on medical devices for various purposes like diagnosis and management of different kind of devices. Various organizations around the world exist which makes policies regarding the management of the marketing and use of such devices. The different kinds of medical instruments are broadly classified into categories depending on their kind and use. The categories are set based on the risk factors associated with these devices, approval for the use of the medical devices depends on clinical tests 1.The major organizations or policymakers of the world who approve the use of the devices are that of United states and European union. These are 2 different organizations with their own set of policies for the approval of the devices 1.For United states, the medical device amendment act of 1976 gives FDA (Food and Drug Administration) the power and authority to get assurance of safety and effectiveness before the marketing the different kinds of medical devices. Each of the devices type is assigned by the FDA are divided into 3 regulatory categories based on its risk to the human body and evolution of the devices which is essential to demonstrate safety and effectiveness. According to the FDA, the class 1 is for low-risk devices like stethoscope and are subjected only to general control tests like sterility, class 2 devices like computed tomographic scanners need to clear general control as well as additional labelling requirements. These devices are labelled moderate risk devices and needs to pass through review path which means it must be previously cleared. Class 3 devices like deep brain simulators needs clinical studies which evaluates the safety as well as the effectiveness of the device and premarket approval 1.Similarly, E.U has its own set of requirements for approval of any medical device. It classifies into 4 different classes: 1, 2(a), 2(b) and 3 based on the risks associated. The control of these devices is monitored by a government body called competent authority. The device with the lowest risk is declared by the competent authority for the confirmation of manufacturing standards. For the approval devices which are more complex, it is given to notified bodies which are independent bodies that specializes in the evolution of such products for the CE mark and for the high-risk devices, clinical data is required 1. There is a need for regulatory body and medical device directive so that they can be tried and tested by various trials to make them appropriate for the patients and good for the environment.