MHRA Updates Guidance on Submitting Clinical Investigation Proposals for Assessment
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Submitting a clinical investigation proposal for MHRA assessment”, dated 6 August 2026.
The guidance explains how manufacturers should prepare and submit clinical investigation proposals for MHRA assessment, including applicable requirements, fees, IRAS submission steps and supporting documentation.
Scope of the Guidance
The guidance applies to clinical investigations conducted in the UK, but the rules for notifying MHRA differ between Great Britain and Northern Ireland.
Clinical investigations conducted in Great Britain must meet the requirements of the Medical Devices Regulations 2002, while clinical investigations conducted in Northern Ireland must meet the requirements of the EU MDR.
Where a clinical investigation includes sites in both Great Britain and Northern Ireland, the submission to MHRA must be made in line with the EU MDR. In this case, a single EU MDR application to MHRA covers sites in both Great Britain and Northern Ireland for the same clinical investigation.
MHRA Fees
MHRA states that a charge applies to all clinical investigation notifications.
Devices are categorised by risk as either Group A or Group B. Group A includes Class I, IIa and IIb devices other than implantable or long-term invasive devices. Group B includes Class IIb implantable or long-term invasive devices, Class III devices and active implantable devices.
The guidance also notes that if a notification is withdrawn within five days of MHRA receiving it, 50% of the relevant fee will be charged; after five days, the full fee will be charged.
Before Notifying MHRA
MHRA highlights that a common reason for objecting to a clinical investigation is failure by the manufacturer to supply the necessary data within the statutory assessment period.
The guidance states that the device under investigation should have been manufactured and tested for safety and performance before an application is submitted to MHRA.
For Great Britain-only investigations, manufacturers must have information demonstrating compliance with relevant essential requirements, except those being investigated. For investigations involving Northern Ireland, manufacturers must have information demonstrating compliance with the relevant General Safety and Performance Requirementsunder Annex I of the EU MDR.
IRAS Submission Requirements
Applications must be made through the Integrated Research Application System.
Manufacturers must complete the IRAS application form and upload the relevant supporting documents. MHRA requires all information to be in English, complete, readable and preferably provided as searchable PDF documents.
Supporting Documentation
The IRAS checklist identifies the documents that should be included in the submission to MHRA.
These include, among others:
covering letter on headed paper;
clinical investigation plan;
investigator’s brochure;
participant information sheet and consent form;
CVs for UK clinical investigators;
device details;
essential requirements or GSPR checklist;
risk analysis;
instructions for use;
device labels;
bench and pre-clinical testing summaries;
clinical experience summary;
list of standards met;
sterilisation validation report, where relevant;
software information, where relevant;
biological safety assessments, where relevant.
Clinical Investigation Plan and Investigator’s Brochure
The guidance states that the clinical investigation plan should be in line with ISO 14155:2026 and include information such as study institutions, intended purpose, mode of action, study design, randomisation, blinding, sample size, patient selection, follow-up and statistical methods.
The investigator’s brochure should also be in line with ISO 14155:2026 and include relevant scientific literature, device classification, device description, intended use, design information, photographs, comparable devices, risk-benefit analysis and user training information.
Device Evidence, Risk Analysis and Testing
MHRA expects device details to be appropriate to the classification, novelty, materials and risks of the device.
The guidance calls for a detailed device description, information on device systems and compatibility, use of ancillary devices, essential requirements or GSPR evidence, and a risk analysis preferably aligned with EN ISO 14971:2019.
Manufacturers should also provide summaries of bench testing and pre-clinical testing, including key test reports, test justifications, acceptance criteria, animal or ex vivo testing where applicable, and any testing conducted to address human factors and usability engineering.
Software, Biological Safety and Sterilisation
For devices that include software, MHRA expects information relevant to stand-alone software or software incorporated into a medical device.
Where possible, software should be designed and maintained according to IEC 62304, with any deviations strongly justified. Minimum information includes software development planning, risk management, configuration management, requirements specifications, verification evidence, problem resolution and release review.
For patient-contacting devices, a biological safety assessment is required, including biocompatibility, risk assessment, material characterisation and haemocompatibility considerations where relevant.
For sterile devices, MHRA requires suitable documentation showing that the sterilisation method renders the device sterile, including sterilisation process details, validation reports, bioburden information and routine monitoring.
Impact on Medical Device Manufacturers
For medical device manufacturers planning clinical investigations in the UK, the updated MHRA guidance reinforces the importance of complete, well-structured and evidence-based submissions.
Manufacturers should pay particular attention to:
whether the study involves Great Britain, Northern Ireland or both;
UK MDR 2002 versus EU MDR requirements;
MHRA fee category and withdrawal timelines;
IRAS submission requirements;
completeness and readability of documentation;
ISO 14155:2026 alignment;
EN ISO 14971:2019 risk analysis;
device description and compatibility evidence;
bench, pre-clinical and clinical experience summaries;
software documentation under IEC 62304;
biological safety, sterilisation and special technology requirements.
For manufacturers, the guidance highlights that clinical investigation readiness depends on having the device manufactured, tested and supported by sufficient technical, clinical and risk documentation before submission to MHRA.
