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• Avoiding delays by proactively identifying outdated or missing data

• The impact of AI and cyber threats on medical devices
• The new cyber challenges 2026 may bring
• How regulators and tech companies are coming to terms with the AI challenge

• Early IVDR‑aligned planning ensures compliant trials and robust validation
• Harmonize multiple CDx pathways to optimize sample use and ensure consistent evidence across regions
• Strong Rx–Dx collaboration is essential for analytical and clinical validation throughout development

Medtech innovators increasingly face a paradox: devices that achieve regulatory success under MDR, FDA, or the AI Act still fail to secure EU HTA endorsement, CMS coverage, or global payer adoption. This session reveals how to engineer evidence strategies that bridge this gap, ensuring that what is clinically compelling also becomes economically undeniable.

We will outline how to design reimbursement-ready clinical programs that anticipate payer requirements without duplicating effort; how to build integrated regulatory-clinical pathways that satisfy Notified Bodies, FDA reviewers, AI Act constraints, and HTA evaluators; and how to leverage PMCF/PMPF, real-world data, and economic modelling to translate regulatory clearance into coding, coverage, payment, and sustainable market access.

Through cross-market case studies and practical frameworks, attendees will learn how to convert approval into adoption, scale, and lasting commercial success.

• Comparing clinical evidence expectations for ophthalmic devices across Asia and Europe
• Highlighting key differences in PMCF interpretation and execution under EU MDR
• Sharing real-world challenges when translating Asia-generated data for European submissions
• Identifying common gaps and misconceptions in cross-regional evidence strategies
• Providing actionable learnings for building sustainable, MDR-aligned clinical and PMCF programs

• Design trials that support both CE marking and joint clinical assessment
• Anticipate decision makers’ expectations when choosing clinical endpoints
• Avoid duplication of evidence generation by aligning early