Active medical devices

An “active medical device” is any medical device relying on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity.

It is, furthermore, a device which depends operatively on a power source or any other energy source (devices that are powered by the human body or by gravity are not included in this definition.) A device, used to transfer energy, substances or parameters between an active medical device and a patient without there being any meaningful change to the energy, substances or parameters, is not seen as an active medical device