Change of https://www.gov.uk/government/publications/clinical-trials-that-include-an-in-vitro-diagnostic-device

Change description : 2026-01-12 09:00:00: 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. [Guidance and regulation]

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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.device

From:
Medicines and Healthcare products Regulatory Agency
Published
1 October 2025
Last updated
12 January 2026 — See all updates

Documents

Clinical trials that include an in vitro diagnostic device

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Details

Definitions

An in vitro diagnostic device (IVD) is a medical device which —

i. concerning a physiological or pathological state,

ii. concerning a congenital abnormality,

iii. to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

iv. to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination. 

A companion diagnostic device

PDF, 240is KB,an 1IVD pagedevice, which is essential for the safe and effective use of a corresponding medicinal product to:

Details
  • identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
  • identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.

    • ThisFurther guidanceinformation coverscan be found in the useGuidance of inon vitrothe diagnosticregulation (of IVD) medical devices in GB.

    Using IVDs in a clinical trial

    IVD devices, including companionincluding diagnostics,companion diagnostic devices, may be used in clinical trials of medicinal products (CTIMPs) to stratify patients for inclusion/exclusion in the trial or stratified to a cohort within a trial.

    For CTIMPs involving an IVD device with sites in Great Britain:

    1. IVD devices including companion diagnostic devices must bear a UKCA or CE mark for use as intended by the manufacturer in a clinical trial.
    2. A health institution exempted device may be used if the IVD device including companion diagnostic devices will be manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity.
    3. Where no device that bears the UKCA or CE marking is available for the clinical trial siteor a health institution exemption does not apply, an analytical performance study should have been conducted prior to the start of the use of the IVD device including companion diagnostic devices with the clinical trial. However, where no analytical performance study has yet been conducted, the characteristics of the IVD device including companion diagnostic devices must be studied. The Tabular Summary that describes the intended performance characteristics of the IVD device or companion diagnostic devices, will be accepted by the MHRA.

    This guidance applies to clinical trial sites in Great Britain.Britain Itand alsoincludes covers situationstrials where patient samples are tested elsewhere,outside the United Kingdom, but where the results are used in patient management decisions in Great Britain. Britain. This guidance does not apply to clinical trials where the results are not used to make patient management decisions in Great Britain. Patient management decisions will include but are not limited to stratification, selection of participants and randomisations into arms of a clinical trial study. For CTIMPs involving an IVD device for performance studies in Northern Ireland, please refer to published guidance on regulation of medical devices in Northern Ireland.

    TheClinical guidancetrials alsowhich definessubsequently determine the clinical performance of the IVD devicesdevice andincluding companion diagnostics,diagnostic anddevices explainsshould be registered.

    Applying for approval of a clinical trial that includes an IVD device

    Applications for approval of a clinical trial that include an IVD device follow the standard approvals process. However, the applicant will need to submit additional information thatabout mustthe beIVD submitteddevice tothrough MHRAthe when applyingIntegrated forResearch approvalApplication System (IRAS) as part of thesethe application package.

    First, the applicant should identify in the covering letter of the application that the clinical trials.trial includes the use of an IVD device.

    Updates

    The covering letter and/or protocol should also confirm that any applicable CE marking requirements have been complied with (or will be complied with prior to thisthe page

    Publishedstudy 1start).

    In Octoberaddition:

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    1. Clarifiedapplicant documentationshould requirementssubmit, whereon a company letterhead, a confirmation that identifies the device manufacturer, their UK responsible person (if applicable) and MHRA device registration on the Public Access Registrations Database (PARD)

    2. if the clinical trial site in GB is notusing a health institution exempted device, the clinical trial applicant should submit, on a company letterhead, a confirmation that includes the UKAS accreditation schedule to ISO 15189 and identifying the device(s) on the schedule
    3. If no UKCA or CE marked,marked anddevice is available or the health institution exemption does not apply.apply, Createdthe publicationMHRA 'Figurerequests 1.either:
      • If Applicationthe processanalytical performance study has been conducted, submit the analytical performance summary report(s) for the IVD device(s), demonstrating evidence of device performance*. The MHRA will assess the analytical performance to ensure the device is suitable for the clinical trialstrial

      4. OR

      • if no analytical performance study has yet been conducted at time of application, a Tabular Summary (MS Word Document, 35.5 KB) should be submitted. This document is a description of the analytical methods including anacceptance IVD'.limits Updatedand publicationparameters 'Clinicalfor trialsperforming thatvalidation. includeThe anMHRA inwill vitroassess diagnosticthe device'tabular summary and will issue a decision letter with allthe outcome. Please supply the contents requested without modifying the structure of thesethe changestemplate.

      AND

      *Analytical sectionperformance means the ability of the device to removecorrectly repetition.detect and/or measure a particular analyte. Analytical performance study refers to technical test performance, which may include data to demonstrate accuracy (derived from trueness and precision), analytical sensitivity (e.g. limit of detection, limit of quantitation), analytical specificity, linearity, cut-off, measuring interval (range), carry-over, as well as determination of appropriate specimen collection and handling, and endogenous and exogenous interference on the results.

    Updates to this page

    Published 1 October 2025

    First published.

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    Update history

    2026-01-12 09:00
    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.

    2025-10-01 11:39
    First published.