New MHRA Guidance on Clinical Investigations Notifications

On 27 August 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated set of flow charts (GB, NI) and accompanying guidance (GB, NI) to help sponsors and manufacturers determine when a clinical investigation notification is required in Great Britain and Northern Ireland.

This update is part of MHRA’s wider efforts to provide greater clarity and consistency for stakeholders navigating the clinical investigation pathway. The flow chart acts as a practical decision tool, guiding users step-by-step through key considerations such as: 

• Whether the planned activity involves human participants 

• The regulatory status of the device (UKCA- or CE-marked, investigational, or in-house) 

• Whether the device is being used within its intended purpose 

• The primary aim of the study (e.g., safety, performance, effectiveness vs. usability or data collection) 

• Specific scenarios such as CTIMPs using devices off-label or health-institution exemptions 

The accompanying guidance provides explanatory notes, examples, and clarifications that help distinguish between studies that require MHRA notification and those that do not. 

For more information about MedEnvoy’s UK Importer service, click here.

Key Differences Between Great Britain and Northern Ireland  

Although MHRA remains the competent authority for both regions, clinical investigation notification requirements differ depending on whether the study takes place in Great Britain (regulated under UK MDR 2002) or Northern Ireland (regulated under EU MDR 2017/745). 

The table below summarises the main areas of divergence that sponsors and manufacturers should be aware of when planning studies across the UK: 

Why it Matters 

• For Great Britain, the rules are narrower and more permissive: most post-market studies are exempt from notification if devices are used as intended. 

• For Northern Ireland, the rules follow EU MDR, meaning certain post-market studies—especially those assessing safety or performance—may still trigger notification. 

Sponsors conducting studies across the UK should carefully review both frameworks to ensure dual compliance where required. 

How MedEnvoy Can Support 

MedEnvoy offers expert regulatory support to manufacturers in navigating MHRA clinical investigation notification requirements. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.