Regulatory competence building in preparation for CE-IVDR for AI support in prostate pathology

Purpose and goal

This project strengthens Clinsight´s internal regulatory competence for CE-IVDR Class C certification of ClinAI, an AI-based clinical decision support system for prostate cancer diagnostics. Working alongside external IVDR experts, the project establishes a regulatory roadmap, compliant technical documentation framework, risk management processes, and a performance evaluation plan, building the internal capabilities needed to manage regulatory submissions independently.

Expected effects and result

Expected outputs include a QMS aligned with ISO 13485, a completed device description and intended purpose, a risk management file, a design and development plan, a GSPR checklist, and a performance evaluation plan and report template. Together, these position Clinsight to manage its CE-IVDR submission and future regulatory requirements independently, directly enabling commercialisation and long-term global competitiveness.

Planned approach and implementation

The project runs May–December 2026 across three sequential work packages. AP-1 establishes the QMS framework and device description; AP-2 develops risk management and design control documentation; AP-3 addresses performance evaluation planning and clinical evidence. Each package is delivered through joint workshops with external consultants, ensuring hands-on knowledge transfer to Clinsight personnel throughout the entire project period.