MDx will present a peer-reviewed poster at the ESMO Congress 2025 in Berlin detailing how our team helped secure IVDR CE marking for a large, service-based germline NGS solution that integrates wet-lab workflows with a validated bioinformatics pipeline. The poster distills a practical, audit-proven pathway that labs and IVD developers can apply when scaling evidence, validating software, and navigating notified-body reviews for complex NGS offerings.
What the poster covers
- Regulatory strategy and intended use: How to right-size scope for very large panels while planning for future expansion.
- Technical documentation: Building Annex II/III files that stand up to Stage I/II audits, including labeling/IFU for service-based models.
- Software validation: Applying IEC 62304/82304 rigor to a bioinformatics pipeline (architecture, V&V, cybersecurity, change control).
- Evidence at scale: A tiered approach to scientific validity and clinical performance, plus a pragmatic PMPF plan to mature low-prevalence evidence.
- Operationalization: Supplier controls, change management, and QMS integration to sustain post-market scalability.
Why this matters
Large NGS panels pose unique IVDR hurdles: non-uniform clinical evidence across thousands of genes, evolving variant knowledge, third-party components without CE marking, and the need to validate bioinformatics as SaMD. By sharing a repeatable pathway and the pitfalls we overcame, this poster offers concrete guidance to shorten timelines without compromising quality or compliance.
When and where to find us
ESMO Congress 2025 takes place 17–21 October in Berlin, Germany. We will publish our poster board number and presentation time here as soon as the session logistics are confirmed by the organizers. If you’re attending, we’d love to meet to discuss your IVDR roadmap.
Read the background
For context on the underlying program and its market impact, explore the public write-ups:
- Fulgent press release on the CE mark for FulgentExome and Fulgent PLM (wet lab + software)
- Citeline case study on pushing IVDR to its limits with next-generation sequencing
- MDx case study with Fulgent on IVDR CE marking for NGS platforms
Ready to talk IVDR CE marking for your NGS product?
Use our contact form to request a 30-minute slot with our regulatory and bioinformatics leads during ESMO 2025, or schedule a virtual follow-up the week after the congress.
