Hello there,
Yes indeed you have an interesting question because procedure packs in the (I will talk about the current ones now) EU MDR and EU IVDR assumes you are mixing apples with apples and not apples and oranges, e.g. medical devices with IVD devices. In fact, the EU IVDR does not even have an Article 22 similar to what exists in the EU MDR. What we did in a somewhat similar experience is having the Notified Body work with us on the review and issuance of a CE Certificate for the medical device portion contained in the IVD - at the time the product was General List so no review of the IVDD was actually performed. We had a "combo" Declaration of Conformity for the finished device which was our declaration against the MDD and IVDD. In the future now many IVD products will be reviewed by Notified Bodies, I think the same thought process would hold true, now you would have 2 CE Certificates with one issued against EU MDR and one issued against EU IVDR. Unfortunately, there is not a ready-method by which medical devices and IVD medical devices can be combined. The challenge you will have is your Notified Body issuing a CE Certificate for the IVD product and how the labelling will be presented for your kit. If the medical device lancet is already CE Marked with a valid CE Certificate, then the Notified Body for the IVD product should accept that. You might have to get creative with the Declaration of Conformity and even the labeling. Certainly I could give you 2 or 3 options you could try with different levels of regulatory risk, but in your situation I would strongly recommend having those discussions with your Notified Body - moving into the EU IVDR world. The difficulty is clearly identifying the lancets are CE Marked by #### Notified Body and the IVD kit CE Marked by #### Notified Body - so your labelling on the zip-lock bag most probably would need to contain that information.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Oct-2020 11:04
From: Anonymous Member
Subject: IVD Kits and EU CE marking
This message was posted by a user wishing to remain anonymous
Dear all,
I hope you can help. I'm posting this anonymously to avoid any embarrassment to my employer.
We are building an IVD kit for sale into the EU which includes a small number of lancets to pierce the patient's fingertip skin to obtain a small blood sample for use in a lateral flow IVD device (which is our device). The lancet is bought in from a supplier and they have confirmed the lancets are EU Class I sterile (with CE by their Notified Body).
The lancets are supplied loose, in bulk, to us, and we break these shipments into zip-lock poly bags for inclusion in our IVD kit. No CE mark is visible on the lancets (they're too small), only the lot number is present; no CE mark is on any bulk packaging of the lancets, and no CE mark is visible on our zip-lock bags containing the lancets. The lancets have no pouch or peel-type packaging; a plastic cap upon the lancet is broken off to expose the sterile lancet within its small plastic housing.
My question is: should the zip-lock bag containing the lancets in our IVD kit be marked with a CE mark by the manufacturer? The IVD Directive is very vague on the subject of IVD kits.
Thank you, in advance, for your views and opinions.
Kind regards,
R