IVD or a general product test kit (if such a thing exists)

Ben S UK

Starting to get Involved
#1
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?
 
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