Mixed OEM CE IVDs sold in a Kit


Hi all, we are having a bit of trouble getting a straight answer on a new product that is being suggested in our company.

We are intending to take 4 IVD products (Vit D test, Iron Deficiency Test etc) that we purchase from two of our OEMs under their own CE mark as finished retail packs, and put all 4 of them into a small cardboard Outer Case to be labelled and sold on pharmacy selves in the UK as a Kit to test several aspects of your health.

We are trying to figure out if this can be done as it raises a lot of questions in terms of how we would control this item in the event of one of the IVDs being recalled etc. There is also a concern that to keep the Kit tracible, we would need to assign a LOT number to it, but as we aren't the manufacturer we are unsure if this can be done.

Having checked the online market space we cant seem to find another example of a mixed IVD kit such as this, except from companies which are the legal manufacturer of all of the IVDs themselves.

We are also trying to figure out if this would be termed as a Procedure Pack or Kit as it doesn't include any MDs as a Procedure Pack and doesnt seem to match the description for a Kit under IVDR; Article 2(11): “‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;”

So essentially, could this be done, and what would we need to consider in terms of launching such a product?

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