CER Template Guide: What a Clinical Evaluation Report Contains

Key Takeaways

• A CER documents the results of the clinical evaluation performed for a medical device and forms part of the device’s technical documentation under EU MDR
• The MDR does not prescribe one mandatory CER table of contents; MEDDEV 2.7/1 Rev 4 provides a proposed structure in Appendix A9
• Core CER sections include the executive summary, scope and device information, clinical background and state of the art, identification and appraisal of clinical data, analysis of clinical data, benefit-risk assessment, and PMS and PMCF evidence
• The CER and the Clinical Evaluation Plan (CEP) are distinct but closely connected: the CEP establishes how the evaluation will be conducted; the CER documents what it demonstrates
• Clinical evaluation continues after market entry; PMCF findings feed directly into the CER and must be reflected in updates throughout the device lifecycle
• Under EU MDR, medical devices use a CER; under IVDR, in vitro diagnostic devices use a Performance Evaluation Report (PER)
• Common CER structure mistakes include treating the report as a collection of study summaries, weak connections between evidence and conclusions, and failure to incorporate post-market evidence

Table of Contents

1. Direct Answer: What Is a Clinical Evaluation Report?
2. Why It Matters: The Role of the CER Under EU MDR
3. How It Works: CER Structure and Key Sections
4. Common Mistakes: CER Structure Problems That Affect Regulatory Review
5. Best Practices: How to Structure a Defensible CER
6. Comparison Table
7. Checklist
8. Definitions
9. Expert Perspective
10. FAQ
11. References
12. Related Resources
13. Call to Action

Direct Answer: What Is a Clinical Evaluation Report?

A Clinical Evaluation Report documents the results of the clinical evaluation performed for a medical device. It is not a standalone literature review. Under Annex XIV of EU MDR, manufacturers must establish and update a Clinical Evaluation Plan, identify relevant clinical data, appraise that data, generate additional clinical data where necessary, and analyse the available evidence to reach conclusions regarding the safety and clinical performance of the device, including its clinical benefits.

The CER represents the documented outcome of this broader clinical evaluation process. Its structure should allow the reader to understand the device and its clinical context, how evidence was identified and evaluated, what the evidence demonstrates about safety and clinical performance, and how it supports the device’s clinical benefits and benefit-risk conclusions.

Why It Matters: The Role of the CER Under EU MDR

Under EU MDR 2017/745, clinical evaluation is a continuous lifecycle obligation. Article 61 requires manufacturers to plan, continuously conduct, and document a clinical evaluation that is based on clinical data and is proportionate to the nature, classification, intended purpose, and risk of the device.

The CER is the primary document through which manufacturers demonstrate to Notified Bodies that their device meets the general safety and performance requirements in relation to clinical evidence. Where notified body involvement is required, the clinical evaluation is assessed as part of conformity assessment, including its relationship with risk management documentation and the technical file.

A poorly structured CER, one that presents study summaries rather than genuine evidence analysis, lacks clear connections between evidence and conclusions, or is inconsistent with post-market surveillance and PMCF findings, is one of the most common reasons conformity assessment is delayed or challenged. For a full breakdown of the most common reasons Clinical Evaluation Reports are rejected during Notified Body review see our dedicated article on this topic.

How It Works: CER Structure and Key Sections

The MDR does not prescribe one mandatory CER table of contents. MEDDEV 2.7/1 Rev 4 provides a proposed CER structure in Appendix A9, which can help manufacturers organise the report according to the device and its clinical evaluation. Although the exact structure may vary, a CER generally needs to communicate several core elements.

Executive Summary

The executive summary provides an overview of the clinical evaluation and its principal findings. It should allow the reader to understand the device being evaluated, the clinical evidence considered, and the overall conclusions regarding clinical benefit and benefit-risk profile without having to interpret the entire report first. MEDDEV 2.7/1 Rev 4 specifically includes a summary addressing the determination and acceptability of the benefit-risk profile in the intended target groups and medical indications.

Scope and Device Information

The scope establishes exactly what is being evaluated. It should clearly identify the device covered by the CER and define its intended purpose, clinical use, and target patient population. Where the evaluation covers multiple models or variants, these should also be clearly identified. The device description should provide enough information to understand how the device works and how it is used clinically.

Clinical Background and State of the Art

The CER should place the device within its current clinical and scientific context. The state-of-the-art assessment may include the relevant medical condition, current treatment or diagnostic options, comparable technologies, expected clinical outcomes, known risks and complications, relevant clinical guidelines, and current scientific literature. Together, these elements provide a benchmark against which the device’s clinical performance, benefits, and risks can be assessed.

Identification of Relevant Clinical Data

Once the scope has been established, relevant clinical evidence must be identified. Under MDR Annex XIV, manufacturers must identify available clinical data relevant to the device and its intended purpose and identify gaps in clinical evidence through a systematic scientific literature review. Article 61 also requires critical evaluation of relevant scientific literature and available clinical investigations.

Potential sources of clinical evidence include clinical investigations of the device, relevant scientific literature, clinical information generated through post-market activities, and data relating to equivalent devices where the applicable MDR requirements for equivalence are appropriately demonstrated.

For literature-derived evidence, the review methodology should make clear how relevant publications were identified and selected, including databases searched, search terms and strategies, date ranges, predefined inclusion and exclusion criteria, and the process used to select relevant publications. A systematic and documented approach helps maintain a traceable connection between the literature search and the evidence incorporated into the CER.

Appraisal of the Clinical Data

Identifying clinical data does not automatically establish that every source is suitable for supporting the clinical evaluation. MDR Annex XIV requires relevant clinical data to be appraised for its suitability in establishing the safety and performance of the device. The appraisal may consider study design and methodological quality, patient population, sample size, clinical endpoints and outcomes, duration of follow-up, potential sources of bias, relevance to the intended purpose, and applicability to the device being evaluated. The CER should make clear how individual sources contribute to the overall clinical evaluation and identify important limitations where appropriate.

Analysis of the Clinical Data

Following appraisal, the relevant evidence must be analysed collectively. This is where the CER moves beyond describing individual studies and asks what the available evidence demonstrates about the device. Key questions include whether the evidence supports the intended purpose, demonstrates expected clinical performance and benefits, supports the safety of the device, adequately represents the relevant patient populations, covers the relevant device models, and identifies any important gaps or uncertainties. The MDR requires the clinical evaluation to be thorough and objective and to take account of both favourable and unfavourable data.

Benefit-Risk Assessment

The clinical evidence contributes to determining whether the benefits associated with the device remain acceptable in relation to its identified risks. Consideration should be given to known adverse events and side effects, potential complications, residual risks, areas of uncertainty, and demonstrated clinical benefits. The conclusions should remain consistent with the device’s risk management documentation and current state of the art. Where uncertainties or gaps remain, these should be identified and addressed through appropriate post-market or clinical activities.

Equivalence, Where Applicable

Clinical data from another device may contribute to a clinical evaluation where equivalence is appropriately demonstrated. Under MDR Annex XIV, equivalence is assessed using technical, biological, and clinical characteristics, supported by appropriate scientific justification. The CER should explain how the relevant equivalence criteria have been assessed and why evidence relating to the proposed equivalent device can appropriately contribute to the clinical evaluation. This section should be included where applicable.

How Does the Clinical Evaluation Plan Fit In?

The CER should not be viewed in isolation from the Clinical Evaluation Plan. Under Annex XIV, the CEP establishes the framework for the clinical evaluation before the resulting evidence is brought together in the CER. The plan includes relevant General Safety and Performance Requirements requiring support from clinical data, the device’s intended purpose, intended target groups and indications, intended clinical benefits and outcome parameters, methods used to assess clinical safety, parameters used to determine benefit-risk acceptability, and the clinical development plan.

In simple terms: the CEP establishes how the clinical evaluation will be conducted. The CER documents what the clinical evaluation demonstrates.

The CER Does Not End at Market Entry

Clinical evaluation continues after the device is placed on the market. Under MDR Annex XIV, PMCF is a continuous process that updates the clinical evaluation. Its objectives include confirming safety and performance throughout the expected device lifetime, monitoring side effects and contraindications, identifying emerging risks, and confirming the continued acceptability of the benefit-risk ratio.

The findings are documented in the PMCF Evaluation Report, which forms part of the CER and technical documentation. New literature, post-market findings, and clinical experience may reinforce existing conclusions, identify new risks, or reveal areas requiring further investigation.

CER vs PER: Don’t Confuse the Terminology

The terminology differs for medical devices and in vitro diagnostic devices.

Under EU MDR, medical devices undergo clinical evaluation, with results documented in a Clinical Evaluation Report (CER). Under EU IVDR, in vitro diagnostic devices undergo performance evaluation, documented in a Performance Evaluation Report (PER).

Common Mistakes: CER Structure Problems That Affect Regulatory Review

Treating the CER as a collection of study summaries

One of the most common structural mistakes is presenting individual study summaries rather than a synthesised analysis of what the available evidence collectively demonstrates. Notified Bodies assess whether the evidence supports the clinical conclusions, not whether studies have been accurately described. A CER that summarises studies without drawing them together into a coherent clinical argument fails to answer the question the evaluation is designed to address.

Inconsistencies across documents

Where the intended purpose, patient population, or clinical claims described in the CER are inconsistent with labelling, risk management documentation, or PMS findings, the clinical evaluation raises questions about whether the documentation presents a coherent account of the device. These inconsistencies are among the most frequent findings during Notified Body assessment.

Weak connections between evidence and conclusions

A CER that presents extensive evidence but does not clearly explain how that evidence supports the benefit-risk conclusion leaves the reader to make the connection themselves. The analysis section must explicitly address what the available evidence demonstrates and where gaps or uncertainties remain.

Inadequate consideration of unfavorable evidence

The MDR requires the clinical evaluation to take account of both favourable and unfavourable data. A CER that emphasises supporting evidence while understating limitations, conflicting findings, or safety signals introduces the risk of selection bias that Notified Bodies specifically assess for. See our article on common literature review challenges for a full breakdown of how evidence selection affects CER quality.

Failing to incorporate post-market evidence

A CER that does not reflect the latest PMCF findings, PMS data, or new literature becomes outdated and creates inconsistencies across the technical file. Clinical evaluation is a continuous process; the CER must reflect the current evidence base, not the evidence available at the time of initial submission.

Best Practices: How to Structure a Defensible CER

A defensible CER tells the clinical evidence story of a medical device clearly and logically. Its structure should make it possible for any informed reader to follow the progression from the clinical question, through the available evidence, to the conclusions of the evaluation.

Start with a clearly defined scope. The intended purpose, target patient population, clinical claims, and device variants covered by the CER should be established at the outset and remain consistent throughout the document and across all related regulatory documentation.

Ensure the state-of-the-art assessment contributes meaningfully to the evaluation. The clinical background should provide a genuine benchmark against which the device’s performance, benefits, and risks can be assessed, not simply a description of the relevant medical condition.

Document the literature search methodology in sufficient detail to allow the search to be reproduced. Databases, search terms, date ranges, and inclusion and exclusion criteria should all be explicitly recorded.

Make the appraisal and analysis sections genuinely evaluative. The appraisal should assess the quality and relevance of each source. The analysis should synthesise what the evidence collectively demonstrates, addressing both supporting and conflicting data explicitly.

Ensure the benefit-risk conclusion is clearly supported by the available evidence and consistent with risk management documentation. Where gaps or uncertainties remain, identify them and explain how they will be addressed through PMCF or other post-market activities.

Keep the CER current. New evidence generated through PMCF, post-market surveillance, and ongoing literature surveillance should be assessed for its impact on the clinical evaluation and reflected in the CER where necessary.

Developing and maintaining a CER requires clinical evidence from multiple sources to remain organised and connected throughout the evaluation process. CiteMed’s clinical evidence management tools support literature screening, clinical data extraction, and the organisation of evidence used during CER development and maintenance, helping medical writers maintain clearer links between source publications, evidence assessments, and the clinical conclusions they support.

Comparison Table: CER vs CEP

Checklist: CER Structure Readiness Under EU MDR

Scope and device information:

• Device, intended purpose, clinical claims, and target patient population are clearly defined
• Device variants and configurations covered by the CER are identified
• Scope is consistent with labelling, risk management documentation, and PMS activities

Clinical background and state of the art:

• Relevant medical condition, treatment alternatives, and comparable technologies are addressed
• State-of-the-art assessment provides a meaningful benchmark for evaluating the device
• Current clinical guidelines and scientific standards are referenced where relevant

Identification and appraisal of clinical data:

• Literature search methodology is documented including databases, search terms, date ranges, and inclusion and exclusion criteria
• Clinical data sources are identified and their relevance to the intended purpose is established
• Appraisal addresses study quality, methodology, patient population, and applicability
• Important limitations are identified and their impact on the evaluation is addressed

Analysis and benefit-risk assessment:

• Evidence analysis addresses what the data collectively demonstrates about safety, performance, and clinical benefit
• Both favourable and unfavourable data are considered
• Benefit-risk conclusion is clearly supported by the available evidence
• Conclusions are consistent with risk management documentation and the current state of the art
• Gaps or uncertainties are identified and addressed through planned PMCF or post-market activities

Equivalence (where applicable):

• Technical, biological, and clinical equivalence criteria have been assessed
• Sufficient access to equivalent device data has been demonstrated
• Scientific justification for the equivalence claim is documented

CEP alignment:

• CER demonstrates that the methodology defined in the CEP was followed
• Evidence requirements established in the CEP are addressed in the CER
• Any deviations from the planned approach are documented and justified

Post-market alignment:

• Latest PMCF findings are reflected in the CER
• PMS findings are considered within the clinical evaluation
• New literature has been assessed for its impact on existing conclusions
• CER update frequency is documented and justified

Definitions

Clinical Evaluation Report (CER)
The document in which a manufacturer compiles, evaluates, and documents the clinical evidence supporting a medical device’s safety, clinical performance, clinical benefits, and benefit-risk profile. Required under Article 61 and Annex XIV of EU MDR, the CER must be maintained throughout the device lifecycle.

Clinical Evaluation Plan (CEP)
The document that defines the scope, methodology, and evidence requirements for the clinical evaluation, including the device’s intended purpose, clinical claims, and planned literature search strategy. Required under Annex XIV of EU MDR. The CEP establishes how the evaluation will be conducted; the CER documents what it demonstrates.

State of the art
The current standard of clinical practice, available treatment alternatives, relevant clinical guidelines, and accepted safety and performance benchmarks in the relevant clinical field. Under Article 61 of EU MDR, clinical evidence must be evaluated in the context of currently available alternatives and the state of the art.

Clinical appraisal
The structured assessment of the quality, relevance, and methodological robustness of clinical data identified for inclusion in the clinical evaluation. Appraisal considers study design, patient population, endpoints, follow-up duration, risk of bias, and applicability to the device’s intended purpose.

Benefit-risk assessment
The formal evaluation of whether the clinical benefits of a medical device outweigh its risks in the context of the available clinical evidence. Must be documented consistently in both the CER and the risk management file throughout the device lifecycle.

Post-Market Clinical Follow-Up (PMCF)
The structured process through which manufacturers actively collect clinical data on their device after market entry. PMCF findings must feed directly into the CER and are a required component of the continuous clinical evaluation under Annex XIV.

Performance Evaluation Report (PER)
The equivalent of the CER under EU IVDR 2017/746. Documents the performance evaluation of an in vitro diagnostic device covering scientific validity, analytical performance, and clinical performance.

Equivalence
The demonstration that a device is equivalent to another device for the purposes of supporting a clinical evaluation using clinical data from that other device. Under MDR Annex XIV, equivalence is assessed using technical, biological, and clinical characteristics.

Expert Perspective

The most consistent structural problem in CERs reviewed during Notified Body assessment is the absence of genuine analysis. The report presents study summaries accurately, the literature search is documented, the appraisal assigns quality scores, and then the analysis section restates what the individual studies found without ever asking what the totality of evidence demonstrates about the device. The benefit-risk conclusion appears at the end as a statement rather than a reasoned outcome from the evidence presented. Notified Bodies can follow this structure and still have no confidence that the clinical evaluation has actually been conducted. The analysis section is where the CER earns its credibility. Everything before it is preparation.

Frequently Asked Questions

What is a Clinical Evaluation Report and what does it contain?

A Clinical Evaluation Report documents the results of the clinical evaluation performed for a medical device under EU MDR 2017/745. It typically contains an executive summary, scope and device information, clinical background and state-of-the-art assessment, identification and appraisal of clinical data, analysis of clinical evidence, benefit-risk assessment, relevant post-market surveillance and PMCF findings, and overall conclusions. The MDR does not prescribe one mandatory CER table of contents; MEDDEV 2.7/1 Rev 4 provides a proposed structure in Appendix A9.

What is the difference between a CER and a CEP?

The Clinical Evaluation Plan (CEP) defines how the clinical evaluation will be conducted, including the intended purpose, evidence requirements, evaluation methodology, and benefit-risk parameters. The Clinical Evaluation Report (CER) documents what the clinical evaluation demonstrates, bringing together the identified clinical evidence and the conclusions it supports. The CER should demonstrate that the methodology defined in the CEP was followed consistently.

How often does a CER need to be updated?

Under EU MDR, there is no single universal CER update schedule based solely on device classification. The CER must be maintained throughout the device lifecycle and updated when new PMCF findings, post-market surveillance data, new literature, or device changes affect the existing clinical evaluation conclusions. The update frequency and rationale should be documented within the CEP.

What is the difference between a CER and a PER?

Under EU MDR, medical devices undergo clinical evaluation documented in a Clinical Evaluation Report (CER). Under EU IVDR, in vitro diagnostic devices undergo performance evaluation documented in a Performance Evaluation Report (PER). The two frameworks have different terminology, evidence requirements, and post-market follow-up obligations.

What are the most common CER structure mistakes?

The most common mistakes include treating the CER as a collection of individual study summaries rather than a synthesised evidence analysis, inconsistencies between the CER and other regulatory documentation such as risk management files and PMS reports, weak connections between the evidence presented and the conclusions drawn, inadequate consideration of unfavourable or conflicting evidence, and failure to incorporate new evidence from PMCF and ongoing literature surveillance. For a full breakdown see our article on reasons Clinical Evaluation Reports are rejected.

What is equivalence in the context of a CER?

Equivalence allows clinical data from another device to contribute to a clinical evaluation where it can be demonstrated that the two devices are equivalent in terms of technical, biological, and clinical characteristics, supported by appropriate scientific justification. Under MDR Annex XIV, specific requirements apply to demonstrating equivalence and to accessing the data necessary to substantiate the claim. The CER should explain how the equivalence criteria have been assessed and why the equivalent device data can appropriately contribute to the evaluation.

How does literature review feed into the CER?

The literature review is the primary mechanism through which relevant published clinical evidence is identified and selected for inclusion in the CER. The search methodology, including databases, search terms, date ranges, and inclusion and exclusion criteria, must be documented to allow the process to be reproduced. The identified literature then undergoes appraisal and analysis within the CER. For guidance on structured literature review methodology see our articles on how to conduct an EU MDR literature review and PRISMA and EU MDR literature review.

References

• Regulation (EU) 2017/745 on medical devices (EU MDR) — particularly Article 61 and Annex XIV
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
• MEDDEV 2.7/1 Revision 4: Clinical Evaluation Guide

Related Resources

• CER Checklist for EU MDR — A practical framework for pre-submission review of Clinical Evaluation Reports
• Why Clinical Evaluation Reports Are Rejected — Common reasons CERs fail Notified Body review and how to avoid them
• CER Writing Services — Expert CER writing and clinical evaluation support for medical device manufacturers
• EU MDR Literature Review Services — Structured literature review supporting CER development and maintenance
• Post-Market Surveillance Under EU MDR — Building a proactive PMS system aligned with EU MDR expectations
• PMCF Surveys Solution — Structured PMCF activities supporting ongoing clinical evidence generation
• PRISMA and EU MDR Literature Review — Structured literature review methodology supporting CER development
• Common Literature Review Challenges — How methodology gaps affect CER quality and regulatory outcomes

Call to Action

If you are preparing a Clinical Evaluation Report, reviewing the structure of an existing CER, or building a more structured approach to clinical evaluation and literature surveillance under EU MDR, Citemeds can help. Get in touch to discuss your requirements.