UK MHRA Guidance: How to Notify a Clinical Investigation for a Medical Device & CTR Signed to Law
- Sharan Murugan
- 21 hours ago
- 3 min read
Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance outlines the procedures, documentation, fees, and responsibilities associated with gaining MHRA approval for clinical investigations. Updated as of April 2025, the guide reflects new procedures for Northern Ireland, in vitro diagnostics (IVDs), and combined reviews with medicines.
A Clinical Investigation is any systematic study involving human subjects to assess a medical device's safety, performance, or effectiveness. These studies are essential for devices that:
Are not yet CE or UKCA marked,
Have a new intended use, or
Require further clinical evidence for regulatory approval.
Notifying the MHRA about your clinical investigation is a legal requirement in the UK. It allows the MHRA to:
Review your study plan to ensure participant safety.
Confirm compliance with regulatory standards.
Provide advice and support during the investigation.
Key Sections of the MHRA Guidance
1. Clinical Investigation Enquiries
Before submitting a notification, you can contact the MHRA for advice or clarification on your planned investigation. This helps ensure your submission is complete and compliant.
2. MHRA Guidance and Validation Checklist
The MHRA provides detailed guidance documents and a validation checklist to help you prepare your notification. This checklist ensures you include all necessary information, such as device details, study design, risk assessments, and investigator qualifications.
3. How to Notify the MHRA
You must submit your notification via the MHRA’s online portal. The notification should include:
A description of the device and its intended use.
The clinical investigation plan includes objectives, methodology, and participant criteria.
Risk analysis and safety measures.
Investigator and site details.
4. Fees
There is a fee associated with the notification process, which varies depending on the type and complexity of the investigation. The MHRA website provides an up-to-date fee schedule.
5. Assessment Process
Once submitted, the MHRA reviews your notification for completeness and compliance. They may request additional information or clarifications. Approval timelines depend on the investigation type but generally aim to be efficient to avoid delays.
6. Combined Review of CTIMP and Medical Device
If your clinical investigation involves both a Clinical Trial of an Investigational Medicinal Product (CTIMP) and a medical device, the MHRA offers a combined review process to streamline approvals.
7. Amendments
If you need to make changes to your clinical investigation after notification, you must notify the MHRA of amendments. This includes changes to the protocol, investigators, or sites.
8. Early Termination or Temporary Halt
If you decide to stop or temporarily halt your clinical investigation, you must inform the MHRA promptly, providing reasons and any safety information.
9. Northern Ireland Specifics
The guidance includes special instructions for clinical investigations conducted in Northern Ireland, reflecting regulatory differences post-Brexit.
10. In Vitro Diagnostic Medical Devices (IVDs)
Separate provisions apply for clinical investigations involving IVDs, reflecting their unique regulatory requirements.
11. Special Circumstances for Healthcare Establishments
Healthcare establishments conducting clinical investigations under specific exemptions must still notify the MHRA and comply with relevant regulations.
12. Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval
Clinical investigations may also require approval from the HRA or HCRW, depending on the location and nature of the study. Coordination between these bodies and the MHRA is essential.
With the growing innovation in digital health and combination products, understanding the updated notification process is essential for medical device developers, CROs, and investigators.
For full details and document downloads, visit the official MHRA guidance page:
Also, check out this press release about "Clinical Trials regulations signed into law" where the UK has signed new clinical trials regulations into law, marking the biggest update in 20 years. These reforms aim to put patient safety at the center, speed up trial approvals, and reduce unnecessary bureaucracy. The changes will streamline processes, require greater transparency, and make the UK more attractive for global research. The new rules will be fully implemented by April 2026 after a 12-month roll-out
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