An MDR-compliant CER shows that benefits outweigh risks using sufficient clinical evidence. Use this outline to keep your CER focused and traceable.
1) Clinical evaluation plan (CEP)
- Intended purpose, claims, and target populations.
- Clinical questions, endpoints, acceptance criteria, and equivalence strategy.
- Literature and data source strategy with inclusion/exclusion criteria.
2) Data identification and appraisal
- Systematic literature search methods and PRISMA flow (if used).
- Appraisal of clinical data quality, bias, and applicability.
- Handling conflicting evidence and data gaps.
3) Equivalence (if applied)
- Technical, biological, and clinical characteristics comparison.
- Access to manufacturer data or justification when limited.
- Evidence that differences do not impact safety/performance.
4) Analysis and conclusions
- Benefit-risk evaluation linked to claims and risk controls.
- Residual risk discussion and need for PMCF.
- Alignment with IFU claims and contraindications.
5) PMS/PMCF linkage and updates
- How PMS signals feed CER updates and PMCF triggers.
- Update frequency by device class and change management rules.
- Summary for SSCP (where applicable).
How MedReg AI helps
- Map your CER to MDCG expectations and Annex XIV.
- Surface weak claims, missing equivalence proof, or thin appraisal sections.
- Generate a gap report to de-risk NB questions before submission.
Need to tighten your CER? Start with a gap analysis and loop in QA/RA. Check /pricing to begin, or contact us via /contact.
