Clinical Evaluation Report Template: EU MDR CER Structure and Traceability

Why a Structured CER Template Matters

Under EU MDR Article 61 and Annex XIV, every medical device — every risk class, no exceptions — must have a Clinical Evaluation Report (CER) as part of its technical documentation. The CER is not a literature review, not a summary, and not a formality. It is a systematically structured document that evaluates all available clinical evidence to demonstrate that the device achieves its intended clinical benefit, that risks are acceptable relative to benefits, and that the evidence is sufficient for CE marking.

Notified Bodies consistently identify CER deficiencies as one of the top causes of nonconformities. The 2024 MedTech Europe MDR/IVDR Survey reported that clinical documentation and technical documentation assessment remain the most frequent sources of review findings, and multiple Notified Bodies cite incomplete clinical evidence and weak CER structure as recurring issues. The gap between a CER that passes review and one that triggers a multi-page deficiency letter is often a matter of structure and traceability — not necessarily the underlying data.

This article provides a complete CER template with section-by-section guidance, example tables, and an evidence traceability matrix. It is a companion to our Clinical Evaluation Report Complete Guide — use that article for methodology and process guidance, and this template to build your actual document.

Regulatory Basis and Key References

Before using this template, understand the governing framework:

CER Document Template: Section-by-Section

Document Header (Every Page)

Document Title:    Clinical Evaluation Report
Document No.:      CER-[Product Code]-[Version]
Device Name:       [Trade Name]
Revision:          [X.X]
Classification:    [Class I/IIa/IIb/III]
Effective Date:    [YYYY-MM-DD]
Next Review Date:  [YYYY-MM-DD] (see update schedule)
Owner:             [Name, Title]
Approved By:       [Name, Title]

Section 1: Scope and Clinical Evaluation Plan

This section defines what the CER covers and how the evaluation will be conducted.

Example: Clinical Evaluator Qualification Table

Section 2: Device Description and Context

Section 3: Clinical Data Sources

3.1 Data Source Identification Table

3.2 Literature Search Protocol Summary

3.3 PRISMA Flow Diagram Reference

Include a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram showing the literature search screening process. This is increasingly expected by Notified Bodies per 2026 guidance.

Section 4: Equivalence Justification (If Applicable)

If clinical data from an equivalent device is used, the manufacturer must demonstrate equivalence per MDCG 2020-5 and Annex XIV Section 3. Three dimensions must be assessed:

Equivalence Assessment Table

Critical requirement: The manufacturer must have sufficient access to the technical documentation of the equivalent device to justify the technical and biological characteristics. If access is limited, equivalence cannot be claimed — a clinical investigation may be required instead.

Section 5: Clinical Data Appraisal

5.1 Data Appraisal Table

For each included clinical data source, assess its quality and relevance:

5.2 Quality Assessment Criteria

Section 6: Clinical Data Analysis

6.1 Performance Outcomes Table

6.2 Safety Data Summary Table

Section 7: Benefit-Risk Analysis

7.1 Benefit-Risk Summary Table

7.2 Benefit-Risk Assessment per ISO 14971 Alignment

Link the clinical benefit-risk assessment to the risk management file:

Section 8: GSPR Compliance Through Clinical Evidence

Map clinical evidence to the specific GSPR that it supports:

Section 9: Data Gaps and PMCF Linkage

This section is critical. Every identified gap in the clinical evidence must be linked to a specific PMCF activity.

9.1 Clinical Data Gap Table

9.2 PMCF-CER Cross-Reference

Section 10: Conclusions

10.1 Conclusion Statements

10.2 Conditions for Conformity

List any conditions under which the conclusions hold (e.g., specific patient populations, use environments, training requirements, or follow-up schedules).

Section 11: Dates, Signatures, and Revision History

Revision History Table

Approval Signatures

Evidence Traceability Matrix

This master traceability matrix links every clinical claim to its supporting evidence, the CER section where it is analyzed, and the GSPR it supports:

CER Update Schedule by Risk Class

Document Quality Checklist

Before submitting the CER to your Notified Body, verify:

Writing Best Practices

Based on Notified Body feedback patterns and industry experience:

1. Write in the third person — the CER is an objective evaluation, not an advocacy document

2. Define all terms — avoid unexplained jargon; if you use "equivalent device," define which device and justify equivalence in Section 4

3. Support every statement with a source — trace every claim to a specific data source, test report, or published reference

4. Use tables over prose — Notified Body reviewers scan tables faster than paragraphs; convert narrative descriptions to structured tables wherever possible

5. Tell a coherent clinical story — the CER should read as a logical progression from device description through evidence to conclusions, not a collection of disconnected sections

6. Address unfavorable data — omitting contradictory evidence destroys credibility; acknowledge it and explain why it does not undermine the overall conclusion

7. Draft CER and PMCF Plan in parallel — the two documents must cross-reference each other explicitly; create a formal data gap table in the CER, then map each gap to a specific PMCF activity

Common CER Nonconformities and How This Template Prevents Them

MEDDEV 2.7/1 Rev. 4 vs. EU MDR Annex XIV vs. MDCG 2020-13

Understanding the relationship between these three documents is essential for CER structure:

Key References

Sources: Regulation (EU) 2017/745 Article 61 and Annex XIV; MEDDEV 2.7/1 Revision 4; MDCG 2020-5, 2020-6, 2020-13; MedTech Europe IVDR & MDR Survey Results 2024; Global RWC EU MDR CER Requirements 2025; Celegence CER Template and CAPTIS structure; PRISMA Statement.