IVDR Scientific Validity Reports: Expert SVR Services for IVD Manufacturers

Frequently Asked Questions

• 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 long does it take to prepare an SVR?

  Under a conventional approach, SVR preparation typically takes 4 to 8 weeks per analyte–indication pair, covering literature search and screening, evidence synthesis, drafting, and QMS sign-off.

  With our AI-enhanced approach, MDx delivers production-ready SVRs in 1 to 2 weeks, without compromising scientific rigour or regulatory defensibility. Our pipeline accelerates literature screening and evidence structuring while keeping expert regulatory review at every step.

• 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.

• What is a Scientific Validity Report (SVR)?

  A Scientific Validity Report (SVR) is a structured technical document that establishes the scientific association between an analyte and a clinical condition or physiological state. It forms the foundation of the evidence chain required to demonstrate an IVD’s clinical utility.

  Under the EU In Vitro Diagnostic Regulation, the SVR is a formally required component of the Performance Evaluation Report (PER). Its scope and content requirements are defined in IVDR Annex XIII, Part A, which mandates a systematic and critical review of available scientific literature to substantiate the claimed analyte–condition relationship.

• When is an SVR required under IVDR?

  An SVR is required for all IVD medical devices seeking CE marking under Regulation (EU) 2017/746. There are no class exemptions, Class A, B, C, and D devices must all include a compliant SVR as part of their Performance Evaluation Report.

  The SVR must also be kept current throughout the device lifecycle. Post-market surveillance findings and new scientific literature may trigger updates, and the document must reflect the state of the art at each regulatory checkpoint.

• What is included in an IVDR Scientific Validity Report?

  A compliant SVR per IVDR Annex XIII, Part A covers three core areas:

  • Systematic literature review A reproducible, protocol-driven search across relevant scientific databases, with transparent inclusion/exclusion criteria and critical appraisal of each included study.
  • Analyte–condition association A synthesised argument demonstrating the biological plausibility and clinical evidence supporting the link between the measured analyte and the target clinical condition.
  • State of the art assessment Benchmarking against current clinical guidelines, reference standards, and comparable technologies to contextualise the device within established medical practice.

  The document must also include a conclusions section that addresses any identified scientific gaps and outlines how remaining uncertainties will be managed through clinical performance evaluation or post-market activities.