MHRA Updates Guidance on Determining Whether a Clinical Investigation Is Required
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Determining if a clinical investigation is required”, dated 23 July 2026.
The guidance applies to England, Scotland and Wales and is intended to help determine whether a medical device study requires notification or application to the MHRA under the UK Medical Devices Regulations 2002.
The document applies to general medical devices and active implantable medical devices only. Separate guidance is available for manufacturers of in vitro diagnostic medical devices and for studies conducted in Northern Ireland.
Purpose of the Guidance
The MHRA guidance provides an explanation of the accompanying clinical investigation flow chart and recommends reviewing the flow chart before reading the explanatory guide.
The document supports sponsors and manufacturers in assessing whether their study falls within the scope of UK MDR 2002 Regulations 16 and 29.
It covers key decision points including whether the study involves human participants, whether the device is used for a medical purpose, whether it is a post-market study, and whether notification to the MHRA is required.
Pre-Clinical, Bench and Retrospective Studies
The guidance explains that studies not involving humans are likely to be considered pre-clinical or bench testing and do not fall within the remit of UK MDR 2002.
Examples include certain retrospective clinical studies and non-interventional software or AI studies using existing data, where there are no safety implications for participants and no patient management decisions are informed by the study.
However, where retrospective data is used to inform patient management, the study should be considered as involving human participants in the decision pathway.
Post-Market Studies and PMCF
The MHRA notes that studies of medical devices and active implantables with a valid UKCA or CE mark, used within their marked indication, are exempt from clinical investigation application requirements under UK MDR 2002 Regulations 16 and 29.
This may include Post-Market Clinical Follow Up activities where a UKCA or CE marked device is further assessed for safety or performance within its intended purpose.
However, if a UKCA or CE marked device is used outside its intended purpose, the study should not be considered a post-market study for that device.
Medical Purpose and Research Tools
The guidance provides clarification on how to assess whether a device is being used for a medical purpose.
Under the UK MDR 2002, a medical purpose includes uses such as diagnosis, prevention, monitoring, treatment or alleviation of disease, compensation for injury or handicap, investigation or modification of anatomy or physiological processes, and control of conception.
The MHRA also explains that some studies may involve devices used as research tools, rather than devices used for a medical purpose. The study context is important, especially where the investigation of a physiological process may be either medical or research-focused.
Where a device has multiple purposes and at least one is a medical purpose, the medical purpose takes precedence in the flow chart decision.
Notification to the MHRA
If the flow chart leads to an outcome where notification is not required, no MHRA application under UK MDR 2002 Regulations 16 and 29 is needed at that point.
However, the MHRA states that all studies intending to use collected data for conformity assessment of the medical device are required to notify the MHRA under Regulations 16 and 29.
Where notification is required, this applies to medical devices that are not UKCA or CE marked, or to devices used for a medical purpose outside their UKCA or CE marking, unless an exemption applies.
Applications are submitted electronically through the Integrated Research Application System.
Impact on Medical Device Manufacturers
For medical device manufacturers and study sponsors in Great Britain, the updated guidance reinforces the importance of assessing the regulatory status of a study before it begins.
Manufacturers and sponsors should pay particular attention to:
whether the study involves human participants;
whether the device is being used for a medical purpose;
whether the device is UKCA or CE marked;
whether the study is within the marked intended purpose;
PMCF and post-market study status;
research tool and non-medical purpose scenarios;
use of retrospective data and AI/software studies;
whether data will support conformity assessment;
whether notification to MHRA is required;
the different requirements applicable in Northern Ireland.
For manufacturers planning clinical activities in Great Britain, the guidance highlights the need to document the decision pathway carefully and reassess the study if the device, protocol or intended use changes.
