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Hi all,
Looking for some advice/counsel please.
We currently have a HLA typing assay IVD that has both IVDD Annex II Loci (A, B, DR) and non-Annex II loci. The product has therefore got an EC Certificate to cover the Annex II intended Use. My question relates to the IVDR "buffer" zone wherein IVDs that have an EC certificate can continue to be sold so long as the certificate is valid (no later than 2024). At the date of application of the IVDR, do we need to remove the non-annex II loci from the intended use? I don't believe so, but was hoping for some comments.
Many Thanks