Archives: Agenda

• Translating past performance data into IVDR-compliant clinical evidence
• Substantiating full intended purpose claims across settings and populations
• Avoiding delays by proactively identifying outdated or missing data

• Leveraging pre-existing data to reduce duplication in MDR submissions
• Avoiding overcommitment and scoping expectations with internal stakeholders
• Case study: Streamlining CER updates for a legacy cardiovascular product

TBC – Adelina Chiaravalloti, Director, Regulatory Affairs and Clinical Evaluation, Corcym

• Streamlining evidence generation without duplicating AI and IVDR submissions
• Understanding notified body expectations for performance claims and bias mitigation
• Identifying realistic validation methods for early-stage digital diagnostics

• Design prospective studies to validate clinical performance of AI
• Clarify intended purpose and risk classification from the outset
• Meet evolving regulatory expectations for AI-enabled systems