Ten document templates covering IVDR performance evaluation, technical documentation, risk management, PMS, notified body prep, and the FDA-to-IVDR gap. Built for US manufacturers entering the EU market.
Instant download. For QA/RA teams at US IVD manufacturers.
Class D devices (HIV, blood typing, tissue typing) were required to have IVDR notified body certificates by May 2025. Class C devices (most infectious disease diagnostics, tumor markers, genetic tests) must comply by May 2026. Class B by May 2027.
The documentation gap from FDA 510(k) to IVDR technical file is substantial. IVDR requires performance evidence — scientific validity, analytical performance, clinical performance per Annex XIII — that FDA does not. Most US manufacturers are building this from scratch under deadline pressure.
From performance evaluation through post-market surveillance.
IVDR Annex XIII compliant PEP covering scientific validity (Part A), analytical performance studies (precision, accuracy, LoD, interference), clinical performance design, and metrological traceability per ISO 17511. Includes section-by-section instructions and auditor expectations.
IVDR Annex II/III line-by-line checklist with Class A/B/C/D requirements mapped. Covers device description, IFU/labeling, GSPR, design/manufacturing, risk management, performance evaluation, and PMS sections. 150+ checkpoints.
ISO 14971:2019 applied to IVDs. Includes IVDR-specific hazard categories: wrong result (false positive/negative), analytical interference (hemolysis, lipemia, cross-reactivity), specimen handling, and use-related hazards for lay users.
IVDR Article 79 and Annex III compliant PMS plan. Includes PMPF requirements for Class C/D, EQA scheme monitoring, PSUR schedule, vigilance reporting thresholds, and KPI dashboard for ongoing performance tracking.
Pre-submission readiness checklist for Class C/D devices. Documents the 10 most common audit findings with specific fixes — including performance evaluation gaps, IVD-specific risk management gaps, and IFU missing elements.
Side-by-side comparison: 21 CFR Part 809 vs. IVDR requirements across labeling, technical documentation, QMS, classification, and post-market reporting. Priority action list for US manufacturers. Data bridging guidance for FDA studies.
IVDR Annex XIII Part A compliance guide. Covers clinical evidence hierarchy, study design options (prospective vs. observational), statistical considerations for sensitivity/specificity targets, and common clinical evidence gaps that delay CE marking.
Full IVDR Annex XIII PER structure. Sections for scientific validity, analytical performance summary, clinical performance data, benefit-risk determination, and conclusions. Mapped to MDCG 2022-9 and MDCG 2023-1 guidance.
Complete validation protocol per IVDR Annex I §9 and CLSI EP series. Covers precision (EP05), accuracy/bias (EP09), LoD/LoQ (EP17), interference (EP07), linearity (EP06), and reference interval studies. Ready to adapt to your device.
Top 10 deficiencies cited by notified bodies in IVDR technical file reviews — with prevention strategies and response templates for each. Based on MDCG guidance and real audit findings. Use as a pre-submission checklist before NB submission.
Class D was May 2025. Class C is May 2026. Class B is May 2027. Most US IVD manufacturers are not ready. The documentation gap from FDA 510(k) to IVDR technical file is larger than most expect.
FDA 510(k) relies on substantial equivalence to a predicate. IVDR does not. You need scientific validity, analytical performance studies, and clinical performance data — documented per Annex XIII. Start with the right structure.
These templates reflect actual IVDR Annex II/III requirements, MDCG guidance, and the gaps notified bodies cite most. Fill in your device-specific data — the hard regulatory architecture is already here.
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Yes. The technical documentation checklist maps to Class A, B, C, and D requirements. The risk management and PMS templates are applicable to all classes. The notified body prep guide is specifically for Class C and D devices requiring third-party review.
Sometimes — with bridging. The gap analysis document (Document 06) walks through exactly when FDA studies can support IVDR requirements and when you need additional studies. IVDR requires scientific validity evidence that FDA does not, so that is almost always a gap.
IVDR applies to in vitro diagnostic devices. MDR applies to medical devices that are not IVDs. IVDR has IVD-specific requirements: Annex XIII performance evaluation (not clinical evaluation), IVDR-specific GSPR elements, and IVD hazard categories in risk management. These templates are built specifically for IVDR — not repurposed MDR templates.
No. This is a practitioner reference toolkit built on IVDR requirements and notified body experience. Consult your regulatory counsel and a qualified EU Authorized Representative for formal compliance opinions and submission strategy.
Ten documents. Start with the structure. Fill in your device data. Submit with confidence.