Clinical Evaluation Reports (CER)
EU MDR/IVDR-compliant CERs and FDA-supportive clinical evaluations. Comprehensive literature search, evidence synthesis, equivalent device analysis, and a benefit-risk determination Notified Bodies and FDA reviewers actually accept.
CER non-conformities are the #1 reason MDR submissions stall
Notified Bodies under EU MDR have raised the bar dramatically since 2021. Generic, template-driven CERs that worked under the old MDD don't pass review today. Notified Bodies issue major non-conformities for inadequate literature search methodology, weak equivalence claims, and benefit-risk reasoning that doesn't engage the actual evidence.
FDA, increasingly, asks for the same rigor in 510(k) and De Novo clinical sections. We build CERs that work for both reviewers, the first time.
A defensible CER, end to end
Literature search with PRISMA flow
Pre-registered search protocol, multi-database execution, screening with reproducible exclusion logic, and a PRISMA flow Notified Bodies expect.
Evidence summary tables
Per-study evidence tables: design, population, endpoints, results, and quality appraisal. Stratified by safety, performance, and clinical benefit.
Equivalent device analysis
Technical, biological, and clinical equivalence analysis matched to MDCG 2020-5 guidance. Equivalence-based or own-data justifications, with the rationale to defend either path.
Benefit-risk synthesis & full CER
Final CER document aligned to MEDDEV 2.7/1 rev 4 structure, with explicit benefit-risk reasoning that engages the evidence rather than recites it.
Pressure-test the evidence, or have us write the full CER
Pick the on-ramp that fits your timeline. Both come with a fixed-fee SOW in 24 hours.
CER scope assessment
We review your existing CER (or current evidence position) against MDR/MDCG and FDA expectations and tell you what's missing.
- 10–15 page gap analysis vs. MDR/MDCG 2020-13
- Equivalence vs. own-data path recommendation
- Top non-conformity risks before NB review
- 1-hour readout call
Full CER
A complete MDR-aligned CER drafted from scratch by senior clinical specialists.
- Pre-registered literature search + PRISMA flow
- Evidence summary tables with quality appraisal
- Equivalent device or own-data analysis
- Full CER document aligned to MEDDEV 2.7/1 rev 4
CER deadline approaching?
Send your device, indication, and current evidence position. You'll get a fixed-fee proposal back within one business day.