IVD in MDR procedure pack

#1
Hi all,

I was hoping for some answers.
We are a legal manufacturer of medical electrical device MDD class IIa. The device drives a needle in the upper layer of the skin, this needle is an accessory in the system, MDD class IIa sterile single use individually packed.

Our supplier provides the injectable liquid, MDD class IIb sterile single use individually packed. The supplier is the legal manufacturer of the liquid.

This supplier also provides a cup for (temporary) storing the liquid. They buy it non-sterile in bulk, then repackage, label and sterilize them. Initially they provide an IVD DoC from the bulk provider (being a sample cup for Centrifichem analyzers), which we did not accept. They say that their notified body indicates the cup is not a MD and does not need CE marking. Irrespectively they now provided their own IVD DoC. So now we receive the cups IVD (general) sterile single use individually packed. The supplier is the legal manufacturer of the cup.


The procedure consist of mounting the needle on the electrical device, pouring the liquid in the cup, dipping the needle in the liquid, and then inject the patient.
We want to provide the user a procedure pack consisting of the needle, the liquid and the cup. Existing packaging and labelling remains intact. Multiple sets are placed in a box with its own label.


Q1: can an IVD device be used in such a procedure with a MD? (indirectly invasive?)

Q2: a procedure pack under article 12 of the MDD seems to be not possible because of the IVD component, so it needs to be under article 22 of the MDR. Is this correct?

Q3: an article 22 declaration by us, and box labelling (without CE mark) have been drafted. Are there any other matters that we need to take care of?

Thanking you all in advance!
 
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#2
Although the cup is supplied as a general IVD consumable, you are assigning an alternate intended use within the kit as you're not using the cup within any examination procedure to provide information (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...). From what I can tell in the MDD or the MDR (though not my area of expertise), there are no restrictions on including IVD medical devices in procedure kits (I've seen this with blood sample containers a lot).
One thing you may need to be careful of (if you are continuing with it as an IVD) is that the MDR only permits IVD's which have been conformity assessed under IVDR and doesn't allow for IVD's certified under the IVDD and utilising transitional arrangements (which will be 90% of IVD's for the next year or two).

From what I can see, you're assigning your own intended purpose (as the current intended purpose assigned by the legal manufacturer should be something to do with sample collection for later examination), which is at best an accessory to contain the liquid and permit aspiration through the needle and could relabel as such.

Hope this helps.
 
#3
Thanks for your elaborate answer! It confirms my reservation I felt with the current construction, as there is possibly a gap between the intended uses.
 
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