`Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:  

- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices,
- providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;

and

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Note 1: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection and storage devices, control materials, and related instruments or apparatus. The information provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate regulations.

Note 2: Products which may be considered to be medical devices in some jurisdictions but for which there is not yet a harmonized approach, are:

- aids for handicapped people,
- devices for the treatment/diagnosis of diseases and injuries in animals,
- accessories for medical devices (see Note 3),
- disinfection substances,
- devices incorporating animal and human tissues which may meet the requirements of the above definition but are subject to different controls.

Note 3: Accessories intended specifically by manufacturers to be used together with a 'parent' medical device to enable that medical device to achieve its intended purpose should be subject to the same GHTF procedures as apply to the medical device itself. For example, an accessory will be classified as though it is a medical device in its own right. This may result in the accessory having a different classification than the 'parent' device.

Note 4: Components to medical devices are generally controlled through the manufacturer's quality management system and the conformity assessment procedures for the device. In some jurisdictions, components are included in the definition of a 'medical device'.