companion diagnostics


Do you need regulatory support for your companion diagnostics device?

Do you want to launch a companion diagnostics device but are unsure about how to manage compliance?

Regulatory Compliance for Companion Diagnostics

Although companion diagnostics are medical tests that are used to determine whether a patient is likely to benefit from a specific treatment, such as a particular drug or not, they are medical devices and specifically tend to be In Vitro devices.

An increasing call for personalised medicine

Companion diagnostics typically involve testing for specific biomarkers, such as genetic mutations or protein levels, that are associated with a particular disease or the response to a specific treatment. The results of these tests can help physicians to make informed decisions about which treatments are most likely to be effective for a particular patient and as such they are part of a move towards personalised medicine.

Regulatory requirements for companion diagnostics

The regulations that apply to companion diagnostics depend on the specific country or region in which they are being marketed. In general, however, companion diagnostics are subject to regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

imed management team

Companion diagnostics in the United States

In the United States, companion diagnostics are regulated as in vitro diagnostic (IVD) devices under the FDA’s Center for Devices and Radiological Health (CDRH). The FDA evaluates companion diagnostics to ensure that they are safe, effective, and reliable for use in guiding treatment decisions. The FDA also requires that companion diagnostics be developed and validated in accordance with established scientific principles and good manufacturing practices.

European Union regulations for companion diagnostics

In the European Union (EU), companion diagnostics are regulated as medical devices under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). These regulations require that companion diagnostics meet specific standards for safety, performance, and clinical evidence before they can be placed on the market. The MDR and IVDR also require that manufacturers of companion diagnostics implement a quality management system (QMS).

Please contact us now on 01295 724286 or email us at, so that we can discuss your situation and support your companion diagnostics product meet the specific regulatory requirements of your target markets.

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