Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) [1] was published on 5 April 2017, becoming applicable on 26 May 2022. At first, the European Bioanalysis Forum (EBF) was not concerned whether the regulations would impact the work in regulated bioanalytical laboratories, as it was our interpretation that the regulated bioanalysis community would only be involved from the sideline and in rare cases only. However, we rapidly noticed an overinterpretation by our community, our stakeholders, and by some regulatory bodies, bringing many biomarkers used in earlier phases of clinical development into the IVDR scope. This stimulated the EBF to get involved in the discussion in trying to bring what we saw as scope creep and the consequences thereof to the table. Hence, the EBF recently intensified informal discussions on the potential impact of the IVDR on activities and assays performed in regulated bioanalytical labs, since a number of EBF member company representatives increasingly voiced concern that some biomarker, immunogenicity and potentially even pharmacokinetic (PK) assays being performed in their labs to support clinical trials of investigational medicinal products were being (rightfully or not) interpreted to fall in scope of the IVDR. Of notable relevance to the EBF community were the increasing number anti-viral capsid antibody assays, biomarker assays, anti-drug antibody (ADA) assays and PCR shedding assays, where bioanalytical data might be used to support patient treatment (medical management) decisions such as inclusion/exclusion, treatment group allocation or discontinuation of post-study monitoring, rather than the traditional end point analysis that most bioanalytical laboratories were accustomed to supporting.