Guidance

Clinical trials that include an in vitro diagnostic device

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 October 2025
• Last updated: 9 March 2026
  Show all updates

  1. 9 March 2026

     Updated wording to align with current guidance on clinical trials that include an IVD.

  2. 12 January 2026

     Clarified documentation requirements where the device is not UKCA or CE marked, and the health institution exemption does not apply. Created publication 'Figure 1. Application process for clinical trials including an IVD'. Updated publication 'Clinical trials that include an in vitro diagnostic device' with all of these changes as well. Amended 'Details' section to remove repetition.

  3. 1 October 2025

     First published.

Documents

Clinical trials that include an in vitro diagnostic device

HTML

Figure 1. Application process for clinical trials including an in vitro diagnostic device

PDF, 311 KB, 1 page

Details

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.