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IVDR or MDR

Discussion in 'EU Medical Device Regulations' started by Chr1sG, Apr 23, 2020.

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  1. Chr1sG

    Chr1sG New Member

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    I'm hoping that someone out there can offer a qualified opinion on the following question:

    When is a device covered by the IVDR and when is it covered by the MDR?

    OK, I know that's a simple question ("just read the definition of an in vitro device" right?) so here's the (long) concrete example I have in mind.

    A patient is connected to an ECMO machine and so their blood is constantly being drawn out, circulated and put back into them (hopefully with a load more O2 on board).
    A nurse wants to take a blood sample to get a measurement of a blood parameter, say glucose level. So he/she finds a vein, sticks in a needle, draws blood into a vacutainer and sends it to the lab. Fair enough.

    But clearly, it would make more sense to use an existing three way port on the external blood circuit and drain some blood into a syringe without needing to puncture a vein somewhere.
    So he/she does that. Obviously, the sample gets sent to the lab and the equipment they use is IVD.

    Now suppose that instead, the nurse uses a hand-held POC device to test the blood sample that he/she has just drawn from the blood circuit. This counts as a 'device for near-patient testing' if my understanding of the IVDR is correct (any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional). But it's still an IVD, right?

    So what if, instead of the nurse drawing blood into a syringe and then depositing that blood into a POC device, what if the POC device is itself connected directly to the 3-way port on the blood circuit (left in the permanently open position) and the device automatically draws blood directly (actively using a pump or even just relying on the pressure in the line to fill a sampling chamber). Perhaps the device performs this blood draw at regular intervals. The blood that is drawn is never put back into the blood circuit.
    Is this an IVD? If not, why not?

    Finally, what if the POC device is actually placed inline with the blood circuit (either directly in the main flow or via a shunt path) and is using a sensing method that does not modify the blood in any way (impedance measurement, optical measurement, who knows what)? The blood that is sampled does not get disposed, but flows back to the patient. Is this an IVD?

    When I read the IVDR, and look at the definition:

    'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
    (a) concerning a physiological or pathological process or state;


    then I can't help thinking that all of the above examples are IVDs. None of them are intended to be used in vivo.

    What do all you wise people have to say?

    Many thanks in advance :)
     
  2. yodon

    yodon Well-Known Member

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    Well, was hoping a wise person would chime in so in the spirit of advancing the discussion, you're stuck with my response.

    I'd think that if it's incorporated in the device, it's just part of the device. I have seen devices that, like you describe, are closed loop - blood drawn from a vein, routed through the device, device does stuff + takes measurements, then routes the (in this case modified) blood back.
     
  3. Chr1sG

    Chr1sG New Member

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    I appreciate the input Yodon. Like you say, I can imagine that it's hard to claim that a totally closed loop system is IVD, but I can't help but think that if a device merely automates blood draw (using an existing port on a blood line) and then performs a near-patient diagnostic test, it wouldn't need to be qualified as anything other than IVD.
    I look forward to further insights from other wise folk loitering on the forum :)
     

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