IMDRF/SaMD WG/N12FINAL:2014
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18 September 2014 Page 8 of 30
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.
3.3.2 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.
3.3.3 Additional considerations for SaMD
SaMD may also:
• Provide means and suggestions for mitigation of a disease.
• Provide information for determining compatibility, detecting, diagnosing,
monitoring or treating physiological conditions, states of health, illnesses or
congenital deformities.
• Aid to diagnosis, screening, monitoring, determination of predisposition;
prognosis, prediction, determination of physiological status.