AI Clinical Evaluation Report Generator
Clinical Evaluation Reports are among the most complex regulatory documents in MedTech. Vespper helps you draft EU MDR-compliant CERs by connecting clinical data, literature reviews, and post-market surveillance into a single, traceable document.
1. Clinical Data Requirements
CERs must demonstrate clinical evidence sufficiency through systematic data collection, appraisal, and analysis.
MEDDEV 2.7/1 Rev 4
- Systematic literature review with documented search methodology and database selection (PubMed, Embase, Cochrane)
- Clinical data appraisal using defined quality criteria and weighting methodology
- Equivalence demonstration requirements — clinical, technical, and biological equivalence per MDCG 2020-5
EU MDR Annex XIV Part A
- Clinical evaluation scope covering all intended purposes and target populations
- State of the art benchmarking against current medical alternatives
- Clinical evidence sufficiency criteria appropriate to device classification and risk
- Literature search must be reproducible — search strings, databases, date ranges, and inclusion/exclusion criteria fully documented
- Data appraisal methodology must be defined before data collection to avoid bias allegations
2. Literature Review Standards
The systematic literature review forms the backbone of most CERs and must follow established scientific methodology.
Systematic Search Methodology
- PICO framework (Population, Intervention, Comparison, Outcome) for search strategy definition
- Database selection criteria — minimum PubMed/MEDLINE, Embase, and Cochrane Library
- Documented inclusion and exclusion criteria applied consistently across all identified literature
Individual Study Appraisal
- Study design classification and evidence level assignment per Oxford CEBM hierarchy
- Risk of bias assessment for each included study
- Data extraction and synthesis methodology documented before analysis begins
- Notified Bodies routinely reject CERs where the literature search is not reproducible from the documented methodology
- Missing appraisal criteria for individual studies is a top-5 deficiency finding in CER reviews
3. Post-Market Surveillance Integration
CERs must incorporate ongoing safety and performance data from post-market surveillance activities.
PMCF Requirements (EU MDR Article 61(11))
- Post-Market Clinical Follow-up study design and results integration
- Vigilance data incorporation per MDR Articles 87-92
- Periodic Safety Update Report (PSUR) cross-referencing and trend analysis
Complaint and Field Data Analysis
- Systematic complaint trend analysis with clinical significance assessment
- Field Safety Corrective Action (FSCA) documentation and impact assessment
- Real-world performance data integration from registries and published post-market studies
- CER must demonstrate a feedback loop between PMS data and clinical evaluation conclusions
- PMCF plan must be consistent with CER update schedule — Notified Bodies check alignment
4. Benefit-Risk Analysis
The benefit-risk determination is the central conclusion of the CER and must be quantified and traceable.
EU MDR Article 61 Benefit-Risk Determination
- Quantitative benefit assessment with defined clinical outcome measures
- Risk characterization using ISO 14971 methodology integrated with clinical evidence
- Comparative benefit-risk analysis against current state of the art alternatives
Residual Risk Acceptability
- Residual risk acceptability criteria documented with clinical justification
- Benefit-risk conclusion supported by the totality of clinical evidence reviewed
- Uncertainty analysis addressing evidence gaps and their impact on conclusions
- Benefit-risk conclusions must be traceable to specific clinical data — not general statements
- Notified Bodies increasingly expect quantitative benefit-risk methodology, not just qualitative narrative
5. Notified Body Expectations
Understanding common deficiency findings helps avoid rejection during Notified Body review.
MDCG 2020-13 (CER Sufficiency Guidance)
- Clinical evaluation plan must define scope, methodology, and update triggers before CER drafting
- Traceability matrix linking every clinical claim to its supporting evidence source
- CER conclusions must be consistent with device labeling, IFU, and risk management file
Common Deficiency Findings
- Insufficient justification for equivalence claims — especially biological equivalence
- Literature search not reproducible from documented methodology
- Missing or outdated PMS/PMCF data integration
- Benefit-risk analysis not quantified or not traceable to specific evidence
- Addressing known deficiency patterns proactively reduces Notified Body review cycles
- Traceability matrix must be comprehensive — every single clinical claim requires a source citation
What happens when documentation falls short
- Notified Body rejection and CE certificate suspension from CER deficiencies
- EU MDR non-compliance leading to market withdrawal across all EU member states
- Patient safety incidents traceable to inadequate clinical evidence documentation
- Delays of 6-18 months in CE marking renewal from CER rewrite requirements
What this means for your team
How Vespper helps you write CERs
Literature and data integration
Upload clinical studies, PMS records, and literature search results as sources. Vespper synthesizes findings and traces every conclusion to its origin.
MDR-compliant structure
Generate CERs following MEDDEV 2.7/1 Rev 4 guidance, with proper sections for scope, clinical data appraisal, benefit-risk analysis, and conclusions.
Evidence traceability
Every clinical claim in your CER links to the specific study, dataset, or literature source it was derived from — ready for Notified Body review.
Iterative revision workflow
When new PMS data arrives or PMCF results are ready, update your CER with AI and review every change before accepting.
Generate your CER in 3 steps
Upload clinical evidence
Connect your clinical investigations, literature appraisals, PMS reports, PMCF data, and prior CER versions.
Generate structured CER draft
Vespper drafts your CER following MEDDEV 2.7/1 Rev 4, with evidence appraisals and benefit-risk conclusions traced to sources.
Review and finalize
Walk through each section, verify citations against source data, accept or refine AI suggestions, and export for Notified Body submission.
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Draft EU MDR-compliant Clinical Evaluation Reports with full evidence traceability.
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