MHRA IVD Clinical Investigations Guidance Update

The Medicines and Healthcare products Regulatory Agency (MHRA) has released an update to its guidance on clinical investigations for in vitro diagnostic (IVD) devices used in Clinical Trials of Investigational Medicinal Products (CTIMPs). The updated guidance provides clarification on the requirements for IVD devices used in these trials in both Great Britain and Northern Ireland.

Key Updates for the MHRA IVD Clinical Investigations Guidance:

• • Conformity Requirements for IVDs in Clinical Trials: All IVDs used in clinical trials of medicines (CTIMPs) must have the relevant conformity mark, such as UKCA, CE, or UKNI, unless exempt. This ensures that the device meets the necessary regulatory standards before being used in a clinical settings.
  • Analytical Performance Studies for IVDs in Great Britain: For clinical trials conducted in Great Britain, manufacturers must provide the MHRA with evidence of the IVD device’s analytical performance. This includes summary reports of performance studies for reagents, equipment, calibrators, controls, and associated software. If no formal study has been conducted, a Tabular Summary description of the device must be submitted. The MHRA has provided a template for this purpose, which can be found here.
  • Regulation of IVDs in Northern Ireland: Clinical trials involving IVDs conducted in Northern Ireland must follow the “Regulation of Devices in Northern Ireland” guidance. This aligns with the European Union’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), ensuring compliance with EU standards. Detailed guidance on conducting clinical investigations and performance studies in Northern Ireland can be accessed here.

These updates offer greater clarity on the regulatory requirements for IVD devices used in clinical trials, particularly around the conformity assessment and performance study reporting for both Great Britain and Northern Ireland. Manufacturers and clinical investigators are encouraged to review the updated guidance to ensure compliance with MHRA regulations.

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