Challenge: A digital health company sought CE marking under IVDR for their AI-powered diagnostic algorithm, with significant classification questions and limited clinical evidence.
Solution: MDx implemented a comprehensive regulatory strategy including:
- Software classification guidance under IVDR rules
- AI algorithm validation protocol development
- Clinical performance study design specific to the algorithm’s diagnostic claims
- Complete technical documentation aligned with IVDR Annex II and IEC 62304
Result: Successful CE marking achieved under IVDR with minimal deficiencies, establishing a regulatory precedent for similar AI-based diagnostics.
Challenge: A precision medicine company needed to develop and validate an NGS-based CDx panel to support a pharmaceutical partner’s targeted therapy application under both FDA and IVDR frameworks.
Solution: MDx designed a harmonized validation approach that satisfied both regulatory pathways:
- Designed analytical and clinical validation studies
- Implemented IEC 62304-compliant software validation
- Created a unified technical documentation package
Result: Successful clinical study execution across 9 European centers, with all validation milestones achieved on time and regulatory submissions accepted by both authorities.
Challenge: A genomics laboratory sought to CE mark their NGS exome sequencing panel targeting over 4,000 genes under IVDR-an unprecedented scale for IVDR certification.
Solution: MDx implemented a comprehensive regulatory strategy including:
- Complete technical documentation for the NGS workflow
- Validation of the bioinformatics pipeline as a medical device
- Implementation of ISO 13485 QMS tailored to NGS operations
- Expert management of the Notified Body submission process
Result: CE mark granted in just 16 months, enabling the client to become one of the first laboratories globally to certify such a comprehensive gene panel under IVDR.
Challenge: An IVD startup needed scientific validity documentation for a novel biomarker with limited published evidence to support their IVDR Class C submission.
Solution: Our AI tools identified related research across multiple databases, including gray literature, preprints, and conference abstracts, while our scientific team extracted and analyzed all relevant data.Result: Produced a comprehensive scientific validity report that established sufficient theoretical basis for the biomarker, allowing the client to proceed with required clinical evidence generation for their Class C submission.
Challenge: A molecular diagnostics company needed scientific validity documentation for 24 biomarkers in their multiplex panel within an aggressive 6-week timeline.
Solution: MDx deployed our AI-enhanced scientific validity process-automatically scanning 15,000+ articles across multiple databases while our expert team validated selections and developed the final reports.
Result: Delivered complete scientific validity documentation for all 24 biomarkers in just 4 weeks-40% faster than conventional methods. All reports passed Notified Body review without major findings.
