Medical device

Intended purpose, not technology, decides whether a product is a medical device, so the same software or instrument can be a device for one company and not for another depending on the claims. Under the EU MDR, a product that achieves its principal intended action by pharmacological, immunological or metabolic means is not a device, although such means may assist it.

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: devices for the control or support of conception; products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

EU MDR, Article 2(1)

any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, 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 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 purposes by means of in vitro examination of specimens derived from the human body, and 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 function by such means NOTE 1 This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic reference [15] (in ISO 13485:2003). [ISO 13485:2003, definition 3.7] NOTE 2 Some differences can occur in the definitions used in regulations of each country. NOTE 3 In conjunction with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 the term “medical device” assumes the same meaning as ME EQUIPMENT or ME SYSTEM (which are defined terms of IEC 60601-1).

IEC 62304:2006+AMD1:2015, clause 3.11

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 1 to entry: 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. [SOURCE: GHTF/SG1/N071:2012, 5.1]

ISO 13485:2016, clause 3.11

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer (3.9) 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 (3.10), — providing information by means of in vitro examination of specimens derived from the human body, and which 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 function by such means Note 1 to entry: Products which can 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. [SOURCE: ISO/IEC Guide 63:2019, 3.7]

ISO 14971:2019, clause 3.10

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 purpose(s) of: — diagnosis, prevention, monitoring (3.35), 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 1 to entry: 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. [SOURCE: ISO 13485:2016, 3.11]

ISO 14155:2020, clause 3.34

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 1 to entry: 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 or human tissues, or both; — devices for in vitro fertilization or assisted reproduction technologies. [SOURCE: ISO 13485:2016,[7] 3.11]

ISO 15223-1:2021, clause 3.12