Clinical Trials That Include an In Vitro Diagnostic Device in the UK

Overview

This guidance explains how to submit an application for approval of a clinical trial that includes an in vitro diagnostic (IVD) device with sites in Great Britain. It also applies where patient samples are tested outside the UK but the results are used in patient management decisions in Great Britain.
Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

Definitions

An IVD device is defined as a medical device used in vitro to examine specimens from the human body for clinical purposes (such as identifying physiological or pathological states, congenital abnormalities, monitoring therapeutic measures, or evaluating donation safety). A companion diagnostic is an IVD essential for the safe and effective use of a related medicinal product, for example to identify patients likely to benefit or at increased risk.
Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

Using IVDs in Clinical Trials

When an IVD device (including companion diagnostics) is used in a clinical trial of an investigational medicinal product (CTIMP):

• The IVD must bear a UKCA or CE mark for use as intended in the trial.
• A health institution exempted device may be used if it is manufactured and used within the same health institution and not transferred.
• Where no marked device is available and exemption does not apply, an analytical performance study should have been done before trial use. If not, characteristics must be studied and described in a Tabular Summary acceptable to the MHRA.
  Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

This guidance applies to trial sites in Great Britain and includes trials where patient management decisions (such as stratification, inclusion/exclusion, and randomisation) depend on IVD results. It does not apply to trials where results are not used for patient management decisions in Great Britain.
Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

Applying for Approval

Applications for clinical trial approval that include an IVD device generally follow the standard CTIMP approvals process, but require additional information about the IVD in the application submitted through the Integrated Research Application System (IRAS).

Applicants should:

• State in the covering letter that the clinical trial includes use of an IVD device.
• Confirm that UKCA or CE marking requirements have been complied with (or will be before the trial starts).
• Provide evidence of marking, exemptions, analytical performance studies, or a Tabular Summary as appropriate.
  Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

Registration and Performance Studies

Clinical trials that determine the clinical performance of the IVD device (including companion diagnostics) should be registered in line with standard clinical trial registration requirements.
Source: Clinical trials that include an in vitro diagnostic device - GOV.UK

Key Points

• IVD devices must meet regulatory requirements for marking or exemption before use in a clinical trial in Great Britain.
• The application requires clear documentation of how the IVD is intended to be used and evidence of conformity or performance data.
• The guidance clarifies roles for sponsors in including IVD components in CTIMPs.
  Source: Clinical trials that include an in vitro diagnostic device - GOV.UK