Thanks for that. That was my thoughts too. The assay is not split into 2xdevices, there is a single intended use which covers all the LOCI that can be typed using this product. A mixture of both Annex II and Non-Annex II. There is currently one risk classification (Annex II, List B), one declaration of Conformity and one IFU and set of labels that holds the Annex II CE Mark (CE+notified body number). The entire technical file was submitted for the CE mark approval.
My concern however is over the wording of the EC certificate. It currently states: abbreviated product name.. reagents (including primers for HLA-A, HLA-B, HLA-DRB)
And one of our other certificates for another product simply states …'reagents for typing HLA-A, HLA-B, HLA-DRB' even though the assay in question also types several other non-Annex II Loci
You guys still think this will be ok to have the List B transition timeframe?
Cheers
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Original Message:
Sent: 21-Sep-2021 02:30
From: Erik Vollebregt
Subject: IVDD To IVDR transition for List B devices
It depends on whether the non-annex II loci are also in scope of the CE certificate for the whole assay. If they are, the transitional regime does not require the manufacturer to basically split the device and remove them from the intended use (and consequently from the certificate). Neither does the MDR by the way for devices with multiple functions in multiple classifications but CE certified under one CE certificate.
It would be different if the assay would already be split in two devices: one Annex II list B with CE certificate for that intended use and the other non-Annex II and self certified for that intended use. In that case the non-Annex II part would need a separte CE certificate by date of application of the IVDR.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 17-Sep-2021 19:17
From: Anonymous Member
Subject: IVDD To IVDR transition for List B devices
This message was posted by a user wishing to remain anonymous
Hi,
I'm hoping someone can help me.
We have a HLA typing assay IVD that has an intended use of typing the Annex II (IVDD) Loci HLA-A, B, DR as well as other non-Annex II Loci. As a result under the IVDD this assay is classed Annex II List B. Under the IVDR transition, Annex II devices with an EC certificate can continue to be manufactured and sold upto 2024 so long as the EC certificate remains valid. My question is around the non-annex II loci within the intended use. Do you believe that we would need to remove those from the Intended Use?
Appreciate your assistance