Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?
could you give some examples for the tests? Usually I would assume that "baseline safety parameters" can be measured using standard CE-marked IVDs. Or are these specific parameters that are exclusively used in the context of a clinical trial?
Best regards, Christoph
These would be baseline safety labs (eg, CBC, LFTs, renal function...).
thanks for the additional information. Taking the approach Ronald posted below respective products for these tests would qualify as IVDs if they are used for diagnosis. In the case of use for inclusion/exclusion in a clinical trial I would argue that the intended purpose is definitely to investigate a physiological or pathological state and that this investigation is done in a medical context to exclude medical risks during the trial. And the examination takes place on specimens taken from the human body so respective products would in my view qualify as IVD. Even if you somehow argue that a clinical trial is not a medical purpose in a narrower sense I think you would still want to use state-of-the-art products and equipment for your analysis - which probably would again lead to CE-marked devices (or respective validated in-house procedures by a qualified laboratory).
I hope this helps. If you have more detailed questions just reach out to me.
Best regards, Christoph
You may be able to answer this question yourself. First step is to detemine if the intended purpose describes a medical purpose. Is the test intended to diagnose, predict, or prognose a disease or disability, or is it investigating a physiological or pathological process or state? If so, it is a medical device and you can go the next step. If not, you can stop and the product should not be considered an IVD under the IVDR. The second step is to determine if it would be considered an IVD. Is it intended to examine specimens taken from the human body to provide information about a physiological or pathological process or state, congenital impairments, predispostion to medical condition or disease, determination of the safety and compatibility with potential recipients, prediction of treatment responses, or for monitoring therapeutic measures? If so, it appears to be an IVD under the IVDR, if not, it will most likely be a medical device.
Reach out if you need help with this.
Ronald, thank you so much. Very helpful!
there is a very useful guidance you can check:
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
If you are using IVD in clinical trial for assessing eligibility and IVD is not commercially available in the country it is considered investigational.
Similar guidance is available for Europe.
Have a great week.
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