Building IVDR compliant panels for haematological disorders

The new IVDR (EU IVDR 2017/746) will ensure that IVD (in vitro diagnostics) products, achieve the highest levels of safety and efficacy possible. Laboratory-developed tests (LDT)/in-house devices (IH-IVD), which constitute a majority of the clinical flow cytometry tests, will now be regulated by the new IVDR.

Under the new regulation, flow cytometry laboratories willing to build their own cocktail of conjugated antibodies for diagnostic purposes can either use:

• Non CE-marked monoclonal antibodies (mAb) Cocktail (RUO, and/or off-label use of CE marked mAb) and bring their cocktail in compliance with IVDR or ensure all article 5.5 requirements including compliance with Annex I General Safety & Performances requirements, EN ISO 15189 or other national provisions related to accreditation, justifying the absence of equivalent devices commercially available, plus adaptations to the QMS to make it appropriate for design and manufacture.
• A CE-marked mAb Cocktail in line with each mAb Instruction for Use (IFU) and intended purpose. The laboratories are not affected by the IVDR and might only have to perform either performance verification or validation, very similar to the current process.

The use of CE-marked mAb cocktails necessitates that all mAbs have Intended Purposes that are consistent with the application (article 5.1*).

This poster provides an overview of the diagnostic purpose of all available IVDR compliant conjugated antibodies.

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