IVDR: our next Challenge? - Brochure

With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the regulations were not intended for. Consequently, cost and timelines are under pressure for these (mostly early clinical development) studies. More and more, we see the regulated BioA lab and the Biomarker Assay lab getting pulled into the IVDR discussions. Hence, as a regulated BioA community we hope to bring the stakeholders together at the workshop and try/help to ensure the IVDR stays within its intended scope, that assays truly in scope follow the required pathway and people understand the substantial associated requirements, and those assays not in scope are not unnecessarily burdened.