OBJECTIVES: The European Medicines Agency's in-vitro diagnostics (IVD) regulation (IVD-R) will roll out over the next 5 years; under IVD-R, Notified Bodies (NBs) will be required to review a larger proportion of IVDs (estimated increase from 8% to 80%). Under IVD-R manufacturers will not only have to demonstrate safety and equivalence of their IVD, but also scientific validity and analytical/clinical performance.

Thought papers have hypothesized IVD-R’s impact on development timelines and evidence requirements. Key concerns include delays in approval timelines due to higher workloads and increases in clinical trial requirements and overall complexity.

While pharmaceutical and diagnostics (Dx) manufacturers have worked to prepare for the entry of IVD-R, uncertainties remain around the long-term impact it will have on pharmaceutical and Dx collaborations, companion diagnostics (CDx), access to targeted medicines, and cost.

This study aims to provide insight into how industry experts are preparing for IVD-R, the impact it has had, and the impact it will have on research and development and evidence needed to support regulatory evaluation and product launch.

METHODS: This study utilized secondary research to understand how pharmaceutical and Dx industries are approaching the development of IVDs, collaborations, and the approach to evidence generation. This research further investigated these topics through qualitative interviews with industry experts across HEOR, access, and commercial functions.

RESULTS: Based on an interim analysis of secondary research, it is expected that IVD-R could delay IVD approvals. Additionally, it will increase evidence requirements for test accuracy and introduce transparency and traceability requirements. This may lead to increased investment and additional pressures on cross-functional manufacturer teams and regional-affiliates as they adjust to these new requirements.

CONCLUSIONS: The upcoming IVD-R implementation is expected to transform evidence requirements and launch timeframes. This will increase the need for more sophisticated pre-, during, and post-launch planning for IVD and CDx products.