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Software as an In Vitro Diagnostic Medical Device
First, before determining whether our software is a CDx or not, we must adequately justify that our software is an In Vitro Diagnostic Medical Device. (according to IVDR).

An In Vitro Medical Device Software (IVDSW) is one that meets the definition of an In Vitro Diagnostic Medical Device. This means that we have a software program used alone or in combination, intended for the study of human samples and whose data comes solely from in vitro diagnostic medical devices. Or its intended use is fundamentally driven by data sources from in vitro diagnostic medical devices.

This software is intended to provide information related to one or more of the following elements:
Related to a physiological or pathological process or state. Related to congenital physical or mental deficiencies; Related to the predisposition to a condition or disease. To determine safety and compatibility with potential recipients. To predict the response or reaction to treatment. To establish or monitor therapeutic measures.
If we analyze the last point, establishing or monitoring therapeutic measures means, among other things, ensuring that the specific medication prescribed by a doctor to a patient is for them. In vitro diagnostic medical devices that have this function must be classified as CDx.

Software whose intended use is to provide information on whether the specific medication determined by the doctor has a higher risk of causing a serious adverse reaction in a patient is a CDx.

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What is a CDx or Companion Diagnostic Test?
The concept of CDx or companion diagnostic test falls within the indications of an in vitro diagnostic medical device. Therefore, if the product under evaluation is software that can be classified as a CDx, it may be an IVDSW.

This means that the software should meet the requirements set out in Regulation (EU) 746/2017 on in vitro diagnostic medical devices if it wants to be marketed in the European Union market with its corresponding CE Marking.

A CDx or companion diagnostic test is a product that is essential for the safe and effective use of a specific medication in order to:
Determine, before or during treatment, which patients may have a higher risk of experiencing serious adverse reactions as a result of treatment with the corresponding medication. Determine, before or during treatment, which patients may have a higher risk of experiencing serious adverse reactions as a result of treatment with the corresponding medication.
In vitro diagnostic products classified as CDx are class C, according to rule 3f). This rule states: “products intended to f) be used as a companion diagnostic test for therapeutic selection are classified as class C.

However, it is necessary to delve into the meaning of the definition of a CDx to determine whether my software is a CDx or not and to avoid classifying a product as a CDx without it actually being one.
What is Not a CDx?
Based on the MDCG 2020-16 v3 guide, we see that CDx are referred to as Companion Diagnostics or Companion Diagnostic Tests. These products are defined as an essential product for the safe and effective use of a medication. Therefore, a CDx is a diagnostic test for the therapeutic selection of a medication already proposed by the doctor.

In this sense, if the product under evaluation determines or proposes among many medications which might be better based on patient variables, it would NOT be a CDx.

The emphasis on before and/or during treatment means that the CDx can be used before the patient starts with that medication to see if it could be beneficial or when they are already on that medication to see if they still benefit or have serious adverse reactions.

On the other hand, products intended to monitor treatment with a medication to ensure the concentration of relevant substances in the human body are NOT a CDx. Similarly, products intended to determine specific quantitative or qualitative markers to establish the dosage of a specific medication for patients who are already eligible to receive that medication are NOT CDx.

For example, a device intended to identify a genotype, unique or multiple genetic and/or genomic variants is a CDx as long as the product is ESSENTIAL for the safe and effective use of THAT medication. Or products intended to identify patients who will benefit from treatment with A specific medication based on the absence of a marker are CDx as long as we are talking about ONE specific medication.

It should be remembered that if we have an in vitro diagnostic medical device that does not fit into any of the specific classification rules, it must be classified as class B.

deviCE Sistemas can help you determine if your software is a CDx or not, or with the qualification and classification of your product, as well as with the CE Marking process, if applicable.