• New requirements for clinical evidence and reports
• "Sufficient clinical evidence"
• Performance evaluation to show scientific validity, analytical performance, and clinical performance
• ISO 20916:2019
• Formal literature search
• Scientific Validity Report
• Analytical Performance Report
• Clinical Performance Report
• Performance Evaluation Report
• Demonstrating clinical utility
• Study designs proportionate to risk level
• Provision for interventional studies
• Evaluation throughout the product lifetime and annual reports
• Performing clinical evidence gap analysis