How Would the European In Vitro Diagnostic Regulation 2017/746 (EU IVDR) Impact Regulated Bioanalysis?

The European Union In Vitro Diagnostic Regulation 2017/746 (EU IVDR) fully came into effect on 26 May 2022, which provides guidance for both commercially available CE-marked IVD and in-house IVD assays (IH IVD). The regulation is initially intended to assure the safety and effectiveness of IVD assays and protect the public health, but it has had an unintended impact on assays that are used to generate data during clinical trials in the EU for inclusion and exclusion, treatment assignment, and safety and efficacy monitoring of the treatment. Of note, the FDA has recently published its final rules on laboratory developed test (LDT) (Docket No. FDA-2023-N-2177) that mirrors the EU IVDR. Therefore, it is critical to assess diligently the evolving context-of-use of a bioanalytical method throughout a clinical development program. Additionally, the bioanalytical community has the obligation to contribute their practical drug development knowledge and experience to aid the health authorities in clarifying and operationalizing EU IVDR in the context of medicinal clinical trials. Rare diseases are characterized by the unmet medical needs such as small patient population, the challenges of infrequent diagnosis, the debilitating illness, and insufficiently efficacious treatment available to the patients. As such, careful considerations are warranted for the selection, development, validation, and strategic placement of a bioanalytical test method to expedite rare disease drug development programs. This presentation will go over key considerations when interfacing EU IVDR and clinical trials. A few examples will be given to highlight the need to appropriately scope a bioanalytical assay in accordance with EU IVDR in support of global clinical studies.