Hello,
I've been trying to understand the delineation between an IVD and a general product test kit (if such a thing exists) - how broad the scope of the IVDR and IVDD are within regards to test kits.
Under the IVDR an in vitro medical device is a medical device (according to MDR article 2) which - amongst other things - is 'intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of providing information on a physiological process or state'
This seems very broad to me and would include kits which aren't intended to be used for the diagnosis, prognosis or recommendation of a treatment.
MDR definition of a medical device also includes devices used for 'investigation of a physiological process or state'.
Is there any additional information on what is regarded as a 'physiological process or state'?
So would a test kit that used a sample such as salvia/urine/stool etc to measure/assess the gut microbiome - with the user being recommended a specific supplement (for general wellness not treatment) be considered an IVD even if no disease state or prognosis was linked to their microbiome profile?
I've been trying to understand the delineation between an IVD and a general product test kit (if such a thing exists) - how broad the scope of the IVDR and IVDD are within regards to test kits.
Under the IVDR an in vitro medical device is a medical device (according to MDR article 2) which - amongst other things - is 'intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of providing information on a physiological process or state'
This seems very broad to me and would include kits which aren't intended to be used for the diagnosis, prognosis or recommendation of a treatment.
MDR definition of a medical device also includes devices used for 'investigation of a physiological process or state'.
Is there any additional information on what is regarded as a 'physiological process or state'?
So would a test kit that used a sample such as salvia/urine/stool etc to measure/assess the gut microbiome - with the user being recommended a specific supplement (for general wellness not treatment) be considered an IVD even if no disease state or prognosis was linked to their microbiome profile?