Medical Devices Write For Us

A medical device is any device intended for medical purposes. Using a device for medical purposes poses significant potential risks. Therefore, before government regulatory authorities allow a machine to be placed on the market in their country, its safety and effectiveness must remain demonstrated with reasonable certainty.

Generally, as the risk associated with a device increases, the number of studies required to demonstrate its safety and effectiveness increases. Furthermore, as the risk increases, the potential benefit for the patient must also increase.

The discovery of what could be considered a medical device by modern standards dates back to ca.400 BC in Baluchistan, where Neolithic dentists used flint-tipped drills and bowstrings. Archaeological studies and Roman medical literature also indicate that many medical devices remained commonly used in Roman times. In the United States, it was not until 1938 that the Federal Food, Drug, and Cosmetic Act (FD&C Act) was introduced regarding medical devices.

Definition

It is difficult to find a comprehensive definition of a medical device because many regulatory authorities worldwide oversee the marketing of medical devices. Although these bodies frequently collaborate and discuss the purpose in general, there are subtle differences in wording that prevent global harmonization of the intention of a medical device, so the appropriate definition of a medical device varies from region to region.

The definition of a medical device is often used to differentiate between medical devices and pharmaceuticals, as the regulatory requirements for both devices are different. In definitions, in vitro diagnostics are frequently recognized as a subclass of medical devices, and accessories remain defined as medical devices.

Risk Classification

Regulatory authorities differentiate between different classes of medical devices founded on their potential for harm if misused, the complexity of their design, and usage characteristics. Each country or region describes these categories in different ways. The authorities also recognize that some devices remain supplied in combination with medicines and that regulating these combination products considers this factor.

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