The Clinical Investigation and Finalised Medical Device

Medical device manufacturers must conduct clinical evaluation to compare a new device to standard of care practice. This section includes considerations needed here for market approval and adoption.

TRL 7–8: Testing in Real-World Settings - Clinical trials, data analysis, and preparing for regulatory approval

At this stage, your device is no longer just a prototype — it's being tested in real clinical environments. This is a critical phase where regulatory documentation, trial execution, and readiness for submission come together. Contact the Joint Research Office early for a discussion.

Jump to read: Study Degisn/Patient and Public Involvement (PPI) | Documentation | Regulatory Approvals

Checklist: Questions to be considered for TRL 7-8

Please work through the questions below and complete the template word document of Medical Device Project Checklist which can be used to initiate dialogue with the UCL Traslational Research Office and the Joint Research Office.

Research, Evidence & Vision 

1. Do you have strong pre-clinical data showing safety and potential effectiveness? 
(This evidence will be essential to justify moving towards clinical testing.) 

2. If your device includes AI, is it now trained and validated for use in a first-in-human trial? 
(Ensure the data pipeline is secure, traceable, and appropriate for regulatory and clinical requirements.) 

3. Are you preparing or ready to begin a Phase 2 trial? 
(This could follow successful first-in-human studies to further evaluate performance or effectiveness.) 

Your Network & Affiliation 

4. Have you explored early adoption opportunities with UCLPartners (UCLP) or discussed with UCL Business (UCLB)? 
(These partners can support evaluation, scale-up, and eventual adoption within NHS settings.) 

Development, Standards & Support Needs 

5. Is your technical documentation or technical file now complete? 
(This includes all design, testing, risk, and performance documentation needed for regulatory submission.) 

6. Do you have access to expert regulatory support to help translate your results into a commercial-ready submission? 
(Support might include CE/UKCA submission, clinical evaluation, or international approvals.) 

7. Have you developed a clear business model or plan for your device? 
(Consider revenue pathways, licensing, or spin-out opportunities.) 

What should be in place between TRL 7–8? 

Technical & Clinical Readiness 

• A finalised functional prototype (design freeze) is being tested in real-world clinical settings. 
• Data is being collected systematically in line with your trial protocol and intended claims. 
• Clinical trials or evaluations are underway to assess safety, usability, and effectiveness. 

Regulatory Readiness (RRL 5–6) 

• You’ve received necessary ethics and regulatory approvals to run trials. 
• Your Design Dossier/Technical File is nearly complete. 
• You've established or accessed a compliant Quality Management System (QMS). 
• Your risk management file and clinical evaluation plan are active and regularly updated. 
• You’ve begun preparing your regulatory submission (e.g., to MHRA, notified body). 

Evidence Generation & Analysis 

• You're collecting clinical data to support safety and performance claims. 
• You're analysing data to inform the Clinical Evaluation Report (CER) or equivalent. 
• Plans for post-market surveillance are being drafted. 

Engagement & Support 

• You're actively working with clinical collaborators, trial units, and regulatory experts. 
• You've identified what support is needed for manufacturing scale-up or further trials. 
• You’re starting discussions around market access, NHS adoption, or spin-out strategy. 

By the end of TRL 8, you should be ready to:

• Submit your regulatory application (e.g., UKCA/CE marking or equivalent). 
• Finalise your clinical evaluation documentation. 
• Prepare for market launch or limited clinical deployment. 
• Have a defined plan for ongoing data collection, post-market monitoring, and commercial strategy.

Potential funding for TRL 7-8 

Visit the UCL Translational Office Sharepoint site.(UCL log-in required)