Hi All, we are starting a Medical Diagnostics company in the New Year, we only plan to supply reagents.
My question is if we sell products as FFMU can we circumvent the need to comply with IVDR directive. We still intend to provide Certificates of Analysis and support for the products and Tech Files.
We won't be selling kits to end user so the labeler will have full responsibility for the product, my understanding is that they will also have to carry out QC on the final kitted products and thus they're ultimately responsible from a legal perspective.
My question is if we sell products as FFMU can we circumvent the need to comply with IVDR directive. We still intend to provide Certificates of Analysis and support for the products and Tech Files.
We won't be selling kits to end user so the labeler will have full responsibility for the product, my understanding is that they will also have to carry out QC on the final kitted products and thus they're ultimately responsible from a legal perspective.