The Global Harmonization Task Force (GHTF), an international harmonization body whose duties are soon to be subsumed by the International Medical Devices Regulators' Forum (IMDRF), has released a final guidance altering how medical devices are defined.
The GHTF final document, SG1-N71:2012 - Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device', makes four changes to existing guidance by modifying the existing definition of 'medical device', defines 'IVD", provides definitions for what constitutes an 'accessory' to both medical devices and IVDs, and makes some further clarifications.
'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical 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 by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
- disinfection substances,
- aids for persons with disabilities,
- devices incorporating animal and/or human tissues,
- devices for.in-vitro fertilization or assisted reproduction technologies.
In Vitro Diagnostic (IVD) Medical Device
'In Vitro Diagnostic (IVD) medical device' means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
Note 1: IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.
Note2: In some jurisdictions, certain IVD medical devices may be covered by other regulations.
Accessory to a medical device
Means an article intended specifically by its manufacturer to be used together with a particular medical device to enable or assist that device to be used in accordance with its intended use.
Accessory to an IVD medical device
Means an article intended specifically by its manufacturer to be used together with a particular IVD medical device to enable or assist that device to be used in accordance with its intended use.
Note: Some jurisdictions include 'accessories to a medical device' and 'accessories to an IVD medical device' within their definitions of 'medical device' or 'IVD medical device', respectively. Other jurisdictions do not adopt this approach but still subject an accessory to the regulatory controls (e.g. classification, conformity assessment, quality management system requirements etc.) that apply to medical devices or IVD medical devices.