MHRA Updates Guidance on Clinical Trials Involving In Vitro Diagnostic Devices

10th October 2025

MHRA Updates Guidance on Clinical Trials Involving In Vitro Diagnostic Devices

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has published revised guidance on submitting applications for clinical trials involving in vitro diagnostic devices (IVDs). Effective from 1st October 2025, the updated guidance outlines the requirements for using IVDs, including companion diagnostics, in clinical trials of investigational medicinal products (CTIMPs) in Great Britain. Key points include:

• IVD Definition: An IVD is a medical device intended for in vitro examination of specimens from the human body to provide information concerning physiological or pathological states, congenital abnormalities, safety and compatibility of donations, or to monitor therapeutic measures.

• Regulatory Requirements:

  • IVDs, including companion diagnostics, must bear a UK Conformity Assessed (UKCA) or CE mark for use as intended by the manufacturer in a clinical trial.

  • A health institution exempted device may be used if the IVD is manufactured and used within the same health institution without being transferred to another legal entity.

  • If no UKCA or CE marked device is available, an analytical performance study should be conducted prior to the trial. If this is not feasible, a Tabular Summary describing the intended performance characteristics of the IVD must be submitted for MHRA assessment.

• Application Process: When applying for clinical trial approval, sponsors must submit additional information about the IVD through the Integrated Research Application System (IRAS), including:

  • Confirmation of UKCA or CE marking or health institution exemption.

  • For unmarked devices, the analytical performance summary report or Tabular Summary.

  • For health institution exempted devices, the UKAS accreditation schedule to ISO 15189.

The MHRA will assess the submitted information and issue a decision letter. If no response is received within 60 calendar days, the application will be rejected.

Link: Clinical Trials that Include an In Vitro Diagnostic Device

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