FAQs
Companion Diagnostics & Biomarker Strategy

Q12: How does FDA CDx regulation differ from EU IVDR requirements for companion diagnostics?

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FDA and the EU IVDR regulate companion diagnostics (CDx) through different models. In the United States, regulation is centralized under the FDA. The agency oversees both the therapeutic product and the CDx. The FDA generally expects the diagnostic and corresponding drug or biologic to be co-developed and approved or cleared contemporaneously when use of the test is essential to the therapy’s safe and effective use. The two labels must be aligned, although FDA may apply regulatory flexibility in particular circumstances. 

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In the European Union, IVDR defines a CDx as a device essential for the safe and effective use of a corresponding medicinal product and generally classifies it as a Class C IVD. The manufacturer undergoes an assessment by an IVDR-accredited Notified Body before CE certification. As part of that review, the Notified Body must seek a scientific opinion on the device’s suitability for the medicinal product from the European Medicines Agency (EMA) or a national medicine authority, depending on the product’s authorization route. The need to coordinate among multiple stakeholders in Europe incentivizes CDx manufacturers to prepare for a long timeline. The Landrich Group has assisted CDx clients in the U.S. and the EU by performing QMS gap assessments, BIMO mock-audits, and inspection readiness training and support.

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