The Medicines and Healthcare products Regulatory Agency (MHRA) is formalising its review process around in vitro diagnostics (IVD) or companion diagnostics (CDx) used in clinical trials, with failure to comply with the new guidelines meaning a trial will not be able to proceed.
Replacing a previous patchwork of guidelines around IVDs or CDx’s (a type of IVD) used in clinical trials, from 28 April 2026, sponsors will need to provide details of the device being used in their trial as part of their Clinical Trial of an Investigational Medicinal Product (CTIMP) submission package.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
For clinical trials in the UK, there currently exists an MHRA and ethics review providing coordinated parallel assessment.
“We intend to implement IVD device assessment into that combined review,” Kingyin Lee, head of clinical trials at the MHRA, explained during a webinar held by the authority on 3 February.
“This will be the biggest update to clinical trial laws in 20 years, with a focus on improving patient safety, trial transparency, and ensuring that we provide a framework that is streamlined, agile and proportionate,” Lee continued.
If an IVD is UKCA or CE-marked and being used in line with that marketing in a trial, participants must outline this detail and provide it within their CTIMP submission through the Integrated Research Application System (IRAS). If not, the submission package will need to include a Health Institute Exemption (HIE). Meanwhile, if an IVD is being used at a site in Northern Ireland (NI), its European Union Medical Device Regulation (EU MDR) designation must be outlined.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAlongside these disclosures, sponsors will need to submit an analytical performance study as part of their submission through IRAS.
Anthony Carter, low risk assessment manager at the MHRA said: “If you do have the analytical performance study report, then you would submit this through IRAs. If you don’t already have an analytical form of study, then we would ask you for the tabular summary instead.”
“As part of the IVD process, there’s going to be a validation window, which is up to seven days. And once we have this seven day validation window, we will be invalidating applications where the IVD documents are not present, because we need them upfront so we can perform this combined process,” Carter continued.
Importantly, Carter also highlighted that sponsors must submit a cover letter in their CTIMP that clearly identifies that an IVD is being used in the submitted trial package to “ensure proper routine for our system”.
By completing this IVD assessment alongside the clinical trial assessment and providing a single outcome, Carter concluded that the MHRA anticipates that the new structure will help reduce duplication and increase transparency around clinical trials that use IVDS.
The growing role of IVDs in trials
Within a clinical trial, IVDs may be used for purposes including specimen examination to determine a physiological or pathological state, a participant’s predisposition to a medical condition or disease, or to predict treatment response or monitor therapeutic measures. Meanwhile, CDxs are used to determine what patients most likely to benefit from a certain therapy, or to identify risk in relation to the reaction of a medication or treatment response.
“IVDs are starting to be used significantly in clinical trial settings, and the role of an IVD device is really to detect or to quantify certain biomarkers to provide actionable clinical data for patient care,” said Joseph Burt, head of diagnostics and general medical devices at the MHRA.
“It can be used for patient selection and stratification, to determine the patient’s eligibility and stratification of participants based on certain biomarkers associated with that clinical trial,” Burt continued.
“IVDs can also be used for monitoring treatment response, and increasingly, IVD devices support ongoing monitoring and treatment of safety and efficacy during clinical trial studies,” Burt added.
In its review process, Burt highlighted that the MHRA will consider the analytical performance of an IVD or CDx and its ability to “correctly, accurately and reliably” detect or measure a specific biomarker, comparing this against the evaluative reports provided in the CTIMP submission.
This broad assessment will include evaluating the sensitivity of a particular device, such as its ability to detect the presence of a biomarker at the lowest concentration; specificity, as in the device’s ability to detect only the biomarker intended, and precision, relating to a device’s ability to consistently and repeatedly show results when the sample is tested multiple times under the same conditions.
