Is a saliva microbiome genetic test a medical device under IVDR?

Question

We are considering developing a test that analyzes microbes present in human saliva using gene sequencing. The test would tell users in general terms if these microbes are associated with certain diseases, but would only provide broad wellness information and generic advice (e.g., "wash your teeth regularly").
The test does not analyze human genes but rather focuses on microbial genetic material. The results might mention associations with diseases (e.g., cardiovascular disease, diabetes), but do not provide a disease diagnosis or definite predisposition.
Given that IVDR Rule 3i and MDCG guidance discuss genetic tests for "heritable traits, diseases or predispositions," does a microbial test like this (with no intended medical purpose) qualify as a medical device under IVDR?

Answer

For clarification: If your intended purpose is simply detection and identification of the microbiome in human saliva based on gene sequencing of bacteria, and there is no medical purpose to the obtained information, it's a bit of a grey area. If you provide information about the presence of certain strains and link it to disease prevention, even in a general way, authorities might see this as having a medical purpose.
If there was a clear medical purpose, I would classify this under IVDR Rule 6, since the aim would be to detect non-life-threatening infectious agents. But if you can show that your intended use is only for general wellness or trivia, and not for diagnosis or prevention, you might be able to argue it is not a medical device. However, interpretations can vary, so it's best to document your intended use very clearly.

Is a saliva microbiome genetic test a medical device under IVDR?

1 Answer

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