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- Digital health and AI
- Regulatory
Designing a clinical investigation protocol for the post-market EU MDR requirements of a Class IIb AI platform
What we did:
Authored a submission-ready protocol, with informed consent and risk management, ready for notified body and ethics submission.
Designed a multi-site clinical investigation to meet the post-market clinical evidence condition attached to the platform's Class IIb EU MDR CE mark.
Defined the study design, endpoints (clinical, workflow and AI-fairness) and statistical approach, aligned with ISO 14155, EU MDR and NHS REC requirements.
Impact:
Delivered a regulator-ready clinical investigation protocol aligned with ISO 14155 and EU MDR clinical evidence requirements, in just six weeks.
Established a repeatable evidence-generation template to support future algorithms on the platform.