Scientific Validity Reports That Accelerate IVDR Compliance
Our unique combination of regulatory expertise and AI-powered literature review delivers compliant, high-quality scientific validity reports with unmatched efficiency-reducing time and cost without compromising quality.
Scientific Validity: The Foundation of IVDR Evidence
EU IVDR 2017/746 demands robust scientific validity documentation for all IVDs-establishing the association between your analyte and a clinical condition through comprehensive literature analysis. MDx delivers authoritative scientific validity reports that withstand regulatory scrutiny while accelerating your path to compliance.
Our scientific validity reports combine regulatory expertise from former Notified Body reviewers with advanced AI-powered literature analysis-ensuring comprehensive coverage of available evidence while significantly reducing turnaround time and cost. Whether you’re developing a novel biomarker or transitioning a well-established test to IVDR, our approach ensures your scientific validity documentation is complete, compliant, and convincing.
Our Scientific Validity Process AI-Enhanced Methodology with Expert Oversight
MDx delivers scientific validity reports through our unique hybrid approach-combining advanced AI literature search tools with expert human analysis and regulatory insight. This methodology maintains full compliance with MDCG 2022-2, MEDDEV 2.7/1 Rev 4, and Notified Body expectations while accelerating delivery and controlling costs.
| Phase |
|---|
| 1. Protocol Development |
| 2. Literature Search |
| 3. Study Selection |
| 4. Data Extraction |
| 5. Evidence Appraisal |
| 6. Report Creation |
| MDx AI-Enhanced Process | Standard Process |
|---|---|
| AI-assisted keyword expansion and search strategy optimization + human validation | Expert development of search strategy |
| AI-powered simultaneous database searches with advanced relevance filtering | Manual searches across multiple databases |
| AI-assisted pre-screening followed by expert validation and selection | Manual screening of titles/abstracts and full texts |
| Machine learning-based data extraction with human verification | Manual extraction of key information |
| AI-supported quality assessment with expert review | Expert evaluation of evidence quality |
| AI-assisted draft generation with comprehensive expert editing and regulatory alignment | Traditional report writing and review |
Key AI Benefits:
- 60% faster delivery without compromising quality
- Enhanced search coverage across multiple databases
- Improved detection of relevant studies with reduced human bias
- Cost savings through optimized processes
- Continual improvement through machine learning
Comprehensive Scientific Validity Solutions
End-to-End Scientific Validity Support
Literature Search Protocol Development
Systematic Literature Reviews
Scientific Validity Documentation
Regulatory & Notified Body Alignment
- Comprehensive documentation for well-known analytes
- Focused searches to capture key evidence
- Efficiency gains through targeted AI search algorithms
- Extensive literature searches across multiple databases
- Identification of related analytes and pathways
- State-of-the-art interpretations
- Gap analysis for clinical evidence planning
- Component-by-component validation
- Algorithm and composite score substantiation
- Interaction and correlation documentation
- Infectious disease
- Oncology & tumor markers
- Genetic testing
- Physiological biomarkers
- Cardiovascular & metabolic disorders
- Autoimmune conditions
- Companion diagnostics
- Point-of-care tests
| Capability |
|---|
| AI-Enhanced Process |
| Regulatory Expertise |
| IVDR Specialization |
| Methodology |
| Scientific Team |
| Turnaround Time |
| Value |
| MDx Advantage | Typical Providers |
|---|---|
 Proprietary AI tools for accelerated delivery |  Conventional manual approach |
| Former NB reviewers from BSI, TÜV SÜD |  Limited regulatory experience |
| 100+ IVDR scientific validity reports | General regulatory consultants |
| MDCG 2022-2 & MEDDEV 2.7/1 compliant with AI enhancement | Basic or outdated methodology |
| PhD-level scientific writers across disciplines | General medical writers |
| 60% faster with our AI-enhanced approach | Slower manual processes |
| 30-40% cost savings through optimized processes | Premium pricing for manual work |
MDx Scientific Writing Team
- Former Notified Body reviewers with direct IVDR experience
- PhD-level scientific experts across clinical domains
- Experienced regulatory writers with IVDR/MDR documentation expertise
- AI specialists with expertise in literature search optimization
- Therapeutic area specialists with deep clinical knowledge
A molecular diagnostics company needed scientific validity documentation for 24 biomarkers in their multiplex panel within an aggressive 6-week timeline.
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.
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.
An IVD startup needed scientific validity documentation for a novel biomarker with limited published evidence to support their IVDR Class C submission.
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.
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.
Frequently Asked Questions
Ask us a Question- How does MDx ensure AI-generated content meets IVDR requirements?
Our AI tools assist with search, screening, and data extraction, but final analysis and conclusions are always developed and validated by our expert team of former Notified Body reviewers and PhD-level scientists. Every report undergoes a comprehensive quality check against MDCG 2022-2 and IVDR requirements.
- What literature databases do you use for scientific validity searches?
Our AI-enhanced approach searches multiple databases simultaneously, including PubMed/MEDLINE, Embase, Cochrane Library, Web of Science, Google Scholar, and specialty databases relevant to your specific analyte. We also search for gray literature, clinical trial registries, and regulatory/government publications.
- How do you handle novel biomarkers with limited literature?
For novel biomarkers, we expand searches to include related biomarkers, biological pathways, and preclinical data. Our AI tools can identify subtle connections in the scientific literature that might be missed through manual searches. We then work with you to determine if the available evidence is sufficient or if additional clinical evidence generation is needed.
- Can you update existing scientific validity documentation to meet IVDR requirements?
Yes. We frequently help clients transition existing documentation to IVDR-compliant scientific validity reports. Our AI tools can rapidly analyze your current documentation, identify gaps, and generate updated reports that meet Annex XIII, Section 1.2.1 requirements.
- How quickly can you deliver scientific validity reports?
Our AI-enhanced approach typically delivers reports 60% faster than traditional methods. Depending on complexity, reports can be completed in 1-2 weeks, compared to the industry standard of 4-8 weeks.
- Do you support MDCG 2022-2 and MEDDEV 2.7/1 Rev 4 compliance?
Absolutely. Our methodology is fully aligned with both MDCG 2022-2 and the principles of MEDDEV 2.7/1 Rev 4, ensuring reports meet current regulatory expectations for systematic literature reviews and scientific validity assessment.
Accelerate Your IVDR Scientific Validity Documentation
Whether you’re launching a novel IVD, transitioning from IVDD to IVDR, or expanding your product claims, MDx delivers scientific validity reports that combine regulatory compliance, scientific rigor, and unmatched efficiency.
Faster, Smarter, Better Evidence Documentation.
