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.
Updated wording to align with current guidance on clinical trials that include an IVD.
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.
Excerpt from the official page. The original is authoritative.