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

Reference number
Coordinator Clinsight AB
Funding from Vinnova SEK 200 000
Project duration May 2026 - December 2026
Status Ongoing
Venture Medtech4Health: Competence Enhancement in SME
Call Medtech4Health: Competence Enhancement in Small Businesses, spring 2026

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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 20 May 2026

Reference number 2026-00614