Performance Evaluation Under EU IVDR for Complex Diagnostics: Multiplex IVDs and Service-Based NGS Panels

Description: Complex diagnostics such as multiplex (multi-analyte) IVDs and service-based next-generation sequencing (NGS) panels offer significant clinical value, but they also attract heightened scrutiny under the EU In Vitro Diagnostic Regulation (IVDR). In practice, many delays and nonconformities arise not from a single missing document, but from misalignment between the intended purpose and claims, classification rationale, the performance evaluation strategy, and the way integrated laboratory and software workflows are defined and controlled.

This combined session provides a practical, implementation-focused roadmap for building and defending an IVDR-ready performance evaluation for complex diagnostic platforms. Using two complementary real-world perspectives—(1) multiplex IVD performance evaluation and Notified Body expectations across scientific validity, analytical performance, and clinical performance; and (2) certification challenges encountered when bringing a large-scale, service-based hereditary cancer NGS panel through IVDR—participants will learn how to structure evidence plans, develop robust Performance Evaluation Reports (PERs), and anticipate typical Notified Body concerns. The session also addresses operational realities that frequently derail submissions, including end-to-end scope definition for wet-lab and software components, modular software validation approaches, management of third-party components, QMS readiness (including transition considerations to ISO 13485), risk management integration, and post-market follow-up planning.

Attendees will leave with actionable tactics to refine claims and intended purpose statements, select defensible evidence generation pathways, and streamline Notified Body interactions for complex, multi-component diagnostics, supported by case-study discussion and audience Q&A.