# Clinical trials that include an in vitro diagnostic device

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/27cf678a-b424-4f19-a7b4-880d986831ef
Type: Guidance
Published: September 30, 2025
Updated: March 9, 2026

> Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.

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## Content

This guidance covers the use of in vitro diagnostic ( IVD ) devices, including companion diagnostics, in clinical trials of medicinal products (CTIMPs) with a trial site in Great Britain. It also covers situations where patient samples are tested elsewhere, but the results are used in patient management decisions in Great Britain. The guidance also defines IVD devices and companion diagnostics, and explains the additional information that must be submitted to MHRA when applying for approval of these clinical trials.

## Attachments

- [Clinical trials that include an in vitro diagnostic device](/government/publications/clinical-trials-that-include-an-in-vitro-diagnostic-device/clinical-trials-that-include-an-in-vitro-diagnostic-device)
- [Figure 1. Application process for clinical trials including an in vitro diagnostic device](https://assets.publishing.service.gov.uk/media/69a726bab9bd90e63a252251/Figure_1_clinical_trials_with_an_IVD.pdf)