Introduction
IVDR transition for precision medicine programs can stall when portfolios span liquid biopsy, RNA-based sequencing, and comprehensive tumor profiling. A leading US-based precision medicine company asked MDx CRO to migrate its oncology diagnostics from self-declared IVDD and FDA pathways to full IVDR certification—without disrupting European market access. This blog shares how we planned the transition, selected the right Notified Body, rebuilt regulatory files, and safeguarded ongoing clinical and CDx development in Europe.
The Challenge
- Convert complex files from FDA/IVDD to IVDR. Multiple assay types (liquid biopsy, RNA-seq, tumor profiling) required re-evidence and restructuring under IVDR Annexes.
- Select the optimal Notified Body. The client needed a partner capable of reviewing a diverse portfolio efficiently and cost-effectively.
- Regulatory documentation lift. We had to redevelop key documents: analytical & clinical performance (including CPS reports), risk and design files, and labeling—while maintaining business continuity.
MDx CRO’s Approach
1) Strategic IVDR roadmap and portfolio triage
We assessed intended purpose, risk class, and evidence gaps for each product, then prioritized quick-win files to protect revenue while scheduling deeper re-verification work for complex assays. This created a clear IVDR transition for precision medicine timeline across the portfolio.
2) Notified Body strategy
Leveraging our knowledge of NB capacity and focus areas, we strategically selected a Notified Body that balanced approval probability, cost, and credibility. Early technical consultations reduced surprises and kept reviews on track.
3) Robust regulatory files
We generated comprehensive IVDR documentation:
- Analytical and clinical performance reports, including scientific validity and performance evaluation reports
- Risk management aligned to Annex I GSPRs
- Design and development files with clear traceability
- Usability and labeling aligned with intended purpose and user context
4) Operational partnership and sponsor duties
The client expanded our role into delegated sponsor responsibilities for clinical studies. We served as EU Legal Representative, oversaw clinical operations, and implemented streamlined processes for biomarker and CDx study submissions across Europe.
Results
- Successful IVDR transition for priority diagnostics with uninterrupted market access in Europe.
- Competitive advantage: stronger operational readiness helped the client attract pharma partners for clinical trial biomarker testing and CDx development.
- Ongoing partnership: MDx CRO manages clinical studies, maintains sponsor duties, and continues the portfolio-wide IVDR journey.
Client Testimonial
“Working with MDx’s Precision Medicine Team has been a pleasure. As a U.S.-based company operating in Europe, I consider them our EU extension. Their expertise and responsiveness keep us ahead in a dynamic market, and the consistency of their delivery has shaped our current and future plans.”
Why This Matters
IVDR raises expectations for evidence, documentation, and lifecycle controls—especially for precision medicine diagnostics. Success requires portfolio triage, NB strategy, and regulatory files that stand up to scrutiny while your teams continue running trials and supporting pharma partnerships. MDx CRO brings integrated regulatory, clinical, and diagnostic know-how to keep your transition moving.
Call to Action
Planning an IVDR transition for precision medicine diagnostics? Let’s protect your market access, cut RFI cycles, and ready your files for Notified Body review.
