Updated: 26th June 2026
Reviewed by: David Small BSc (Hon), MSc, MTOPRA (Founder and CEO)
What Is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a structured document that demonstrates a medical device achieves its intended purpose, performs as intended and that its clinical benefits outweigh any associated risks throughout its lifecycle. Required under Article 61 and Annex XIV of Regulation (EU) 2017/745 (EU MDR), the CER brings together all relevant clinical evidence to support conformity with the General Safety and Performance Requirements (GSPRs).
Rather than presenting new clinical data, the CER critically evaluates existing evidence. This may include published scientific literature, clinical investigation data, Post-Market Clinical Follow-up (PMCF) findings, Post-Market Surveillance (PMS) data, registry information and other clinically relevant sources. The objective is to demonstrate that the available evidence is sufficient to support the device’s safety, performance and intended clinical benefits.
The Clinical Evaluation Report forms a key part of the Technical Documentation submitted for conformity assessment. For devices requiring Notified Body involvement, it is one of the most heavily scrutinised documents during the CE marking process and is routinely reviewed throughout the product lifecycle as new clinical evidence becomes available.
Unlike the Clinical Evaluation Plan (CEP), which defines how the evaluation will be conducted, the CER documents the results of that evaluation, presents the supporting evidence, assesses its quality and explains the conclusions reached by the manufacturer.
A Clinical Evaluation Report should demonstrate:
- The device achieves its intended medical purpose.
- Clinical benefits outweigh any known or foreseeable risks.
- Clinical evidence is sufficient for the device’s risk classification.
- The device complies with the applicable General Safety and Performance Requirements (GSPRs).
- Residual risks remain acceptable when weighed against the expected clinical benefits.
- Clinical evidence continues to support the device throughout its market lifecycle through ongoing review and updates.
Need an Introduction to Medical Device Clinical Evaluation?
This article focuses specifically on Clinical Evaluation Report requirements under the EU MDR. If you're looking for a complete overview of medical device clinical evaluation, including Clinical Evaluation Plans, clinical evidence, State of the Art, PMS, PMCF and CER updates, read our Complete Guide to Medical Device Clinical Evaluation.
Why Is a Clinical Evaluation Report Required Under the EU MDR?
The EU MDR places significantly greater emphasis on clinical evidence than its predecessor, the Medical Devices Directive (MDD). Manufacturers must not only generate sufficient clinical evidence before placing a device on the market but also continually review that evidence throughout the product’s lifecycle. The Clinical Evaluation Report (CER) is the document that demonstrates this has been achieved.
A CER provides objective evidence that a medical device is safe, performs as intended and delivers the clinical benefits claimed by the manufacturer. It also demonstrates that the available clinical evidence is appropriate for the device’s intended purpose, classification and risk profile.
For many manufacturers, the CER becomes one of the most important documents within the Technical Documentation because it brings together evidence from across the quality management system into a single, structured assessment.
The Clinical Evaluation Report demonstrates that:
| Requirement | How the CER Addresses It |
|---|---|
| Device safety | Evaluates whether identified risks remain acceptable when weighed against clinical benefits. |
| Clinical performance | Demonstrates that the device performs as intended under normal conditions of use. |
| Clinical benefits | Provides objective evidence that the intended medical benefits are achieved. |
| Benefit-risk acceptability | Assesses whether the overall benefits outweigh any residual risks. |
| GSPR compliance | Supports compliance with the applicable General Safety and Performance Requirements relating to clinical safety and performance. |
| Clinical evidence | Demonstrates that sufficient high-quality clinical data support the manufacturer’s claims. |
| Lifecycle compliance | Shows how ongoing PMS, PMCF and published clinical evidence continue to support the device after CE marking. |
More Than a Regulatory Requirement
A well-prepared Clinical Evaluation Report is not simply a document produced to satisfy regulatory requirements. It provides the clinical justification for placing a medical device on the market and supports many other elements of the Technical Documentation, including Risk Management, labelling, Instructions for Use (IFU), Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).
Because clinical evidence evolves over time, the CER is considered a living document that should be reviewed and updated whenever significant new evidence becomes available, ensuring the device continues to comply with the EU MDR throughout its lifecycle.
What Should a Clinical Evaluation Report (CER) Contain?
Although every Clinical Evaluation Report should be tailored to the specific medical device, intended purpose and risk classification, Annex XIV of the EU MDR and MEDDEV 2.7/1 Rev. 4 establish clear expectations regarding its structure and content. A well-organised CER enables regulators and Notified Bodies to understand how the manufacturer has evaluated the available clinical evidence and reached their conclusions.
Rather than simply compiling clinical studies, a CER should present a logical, evidence-based assessment that demonstrates the device is safe, performs as intended and continues to achieve a favourable benefit-risk profile throughout its lifecycle.
Typical Contents of a Clinical Evaluation Report
| CER Section | Purpose |
|---|---|
| Executive Summary | Provides a concise overview of the device, methodology, key clinical evidence and overall conclusions. |
| Device Description | Describes the device, intended purpose, indications, target patient population, classification and relevant technical characteristics. |
| Scope of the Evaluation | Defines the objectives of the Clinical Evaluation and the regulatory framework under which it has been performed. |
| State of the Art | Reviews current clinical practice, alternative treatments and accepted standards of care to establish the clinical context for evaluating the device. |
| Clinical Background | Explains the medical condition being treated or diagnosed and the clinical need addressed by the device. |
| Clinical Evidence Identification | Describes the systematic approach used to identify relevant clinical data, including literature searches, clinical investigations, PMCF data and Post-Market Surveillance information. |
| Critical Appraisal of Evidence | Evaluates the quality, relevance and scientific validity of each source of clinical evidence, identifying strengths, limitations and potential bias. |
| Clinical Data Analysis | Integrates all available evidence to determine whether the device achieves its intended clinical performance and remains safe for its intended users. |
| Benefit-Risk Assessment | Assesses whether the demonstrated clinical benefits continue to outweigh any known or foreseeable residual risks. |
| Conclusions | Summarises the findings of the Clinical Evaluation and confirms whether sufficient clinical evidence exists to support continued EU MDR compliance. |
| References and Appendices | Includes literature search strategies, referenced publications and supporting documentation used during the evaluation. |
Evidence Should Lead the Conclusions
One of the most common weaknesses identified during Notified Body reviews is a Clinical Evaluation Report that contains extensive background information but provides insufficient analysis. The CER should not simply list published studies or summarise clinical data—it should critically evaluate the evidence, explain its relevance to the device and demonstrate how the evidence supports the manufacturer’s conclusions.
Every conclusion within the report should be traceable to objective clinical evidence and remain consistent with the device’s Risk Management documentation, General Safety and Performance Requirements (GSPRs), labelling, Instructions for Use (IFU) and Post-Market Surveillance activities. A clear, evidence-based narrative not only supports regulatory compliance but also makes the CER significantly easier for reviewers to assess during conformity assessment.
How Clinical Evidence Is Collected and Evaluated
The strength of a Clinical Evaluation Report depends on the quality of the clinical evidence it contains. Under the EU MDR, manufacturers are expected to identify, assess and critically evaluate all relevant clinical data using a systematic and scientifically justified methodology. The objective is not to gather as much information as possible, but to ensure that the evidence is relevant, reliable and sufficient to demonstrate the device’s safety and performance.
Clinical evidence should be proportionate to the device’s intended purpose, classification, novelty and risk profile. A Class III implantable device, for example, will typically require significantly more robust clinical evidence than a low-risk Class I device.
Common Sources of Clinical Evidence
A Clinical Evaluation Report may draw upon multiple evidence sources to build a comprehensive assessment.
| Evidence Source | How It Supports the CER |
|---|---|
| Published Scientific Literature | Demonstrates clinical safety, performance and current scientific knowledge relating to the device or equivalent technologies. |
| Clinical Investigation Data | Provides direct clinical evidence generated from studies involving the device under evaluation. |
| Post-Market Clinical Follow-up (PMCF) | Confirms the device continues to perform safely and effectively under real-world conditions following CE marking. |
| Post-Market Surveillance (PMS) | Supplies complaint data, trend analysis, adverse events and customer feedback to support ongoing clinical evaluation. |
| Vigilance Reports | Identifies safety signals and evaluates whether corrective actions are required. |
| Clinical Experience | May include registry data, published case series or other documented real-world clinical experience where appropriate. |
| Equivalent Device Data* | May be used where equivalence can be robustly demonstrated in accordance with EU MDR requirements. |
*The use of equivalent device data has become significantly more restricted under the EU MDR and must be fully justified with appropriate technical, biological and clinical evidence.
Critical Appraisal Is Essential
Simply collecting clinical evidence is not sufficient. Each source should be critically appraised to determine:
- Its scientific quality and methodological robustness.
- Whether the patient population reflects the device’s intended users.
- The relevance of the outcomes measured.
- Potential sources of bias or limitations.
- Whether the evidence remains current and reflects the present state of the art.
- How well the evidence supports the manufacturer’s intended purpose and clinical claims.
Where evidence is inconsistent or limited, the manufacturer should explain how any uncertainties have been addressed and whether additional clinical data or Post-Market Clinical Follow-up (PMCF) activities are required.
Demonstrating an Evidence-Based Conclusion
The final conclusions within the Clinical Evaluation Report should be based on the totality of the available clinical evidence rather than a single study or publication. By considering all relevant data together, manufacturers can demonstrate that the device continues to achieve its intended purpose, that its benefits outweigh any residual risks and that sufficient clinical evidence exists to support continued compliance with the EU MDR.
What Do Notified Bodies Look for in a Clinical Evaluation Report?
For medical devices requiring Notified Body assessment, the Clinical Evaluation Report (CER) is one of the most thoroughly reviewed documents within the Technical Documentation. Notified Bodies assess not only whether a CER exists, but also whether it demonstrates, through objective clinical evidence, that the device is safe, performs as intended and complies with the applicable requirements of the EU MDR.
A well-prepared CER should present a clear, logical and evidence-based justification for the manufacturer’s conclusions. Every claim made within the report should be supported by robust clinical evidence and remain consistent with the wider Technical Documentation.
Areas Commonly Reviewed by Notified Bodies
| Assessment Area | What Reviewers Expect to See |
|---|---|
| Device Description | A clear description of the device, intended purpose, indications, target population and classification. |
| Clinical Evaluation Methodology | A systematic and well-documented approach to identifying, selecting and evaluating clinical evidence. |
| Literature Search Strategy | Comprehensive, reproducible literature searches using appropriate databases, search terms and inclusion/exclusion criteria. |
| Clinical Evidence | Relevant, current and sufficient clinical data appropriate for the device’s risk classification and intended purpose. |
| Critical Appraisal | An objective assessment of the quality, strengths and limitations of each source of clinical evidence. |
| State of the Art | A well-defined review of current clinical practice and available alternative therapies or technologies. |
| Benefit-Risk Assessment | Clear justification that the device’s clinical benefits outweigh any identified residual risks. |
| Consistency Across Documentation | Alignment between the CER, Risk Management File, Instructions for Use (IFU), labelling, GSPRs, PMS and PMCF documentation. |
| Lifecycle Maintenance | Evidence that the CER is reviewed and updated as new clinical evidence becomes available. |
Common Reasons Clinical Evaluation Reports Are Challenged
Even where manufacturers have invested significant effort into preparing a CER, deficiencies are frequently identified during conformity assessment. Some of the most common issues include:
- Literature searches that are poorly documented or cannot be reproduced.
- Clinical evidence that is outdated or no longer reflects the current state of the art.
- Reliance on claims without sufficient supporting evidence.
- Weak or unsupported equivalence justifications.
- Inconsistencies between the CER and the Risk Management File, labelling or intended purpose.
- Insufficient discussion of benefit-risk or residual risks.
- Failure to incorporate Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) findings into the evaluation.
- Clinical Evaluation Reports that have not been updated following significant product changes or new clinical evidence.
Building a CER That Withstands Review
A Clinical Evaluation Report should tell a clear and evidence-based story. From the initial literature search through to the final conclusions, every section should demonstrate how the available clinical evidence supports the safety, performance and intended purpose of the device.
Manufacturers that maintain their CER as a living document—regularly incorporating new clinical data, PMS findings and PMCF results—are generally better prepared for Notified Body reviews and are more likely to achieve a smoother conformity assessment process.
Need to Understand the Latest MDCG Expectations?
Medical Device Coordination Group (MDCG) guidance continues to shape how manufacturers prepare Clinical Evaluation Reports under the EU MDR. Discover the latest expectations for clinical evidence, equivalence, Post-Market Clinical Follow-up (PMCF), benefit-risk assessment and Notified Body reviews in our Clinical Evaluation Under MDR: 2025 MDCG Updates.
When Should a Clinical Evaluation Report Be Updated?
A Clinical Evaluation Report (CER) is not a document that is completed once and then archived. Under the EU MDR, Clinical Evaluation is a continuous process, meaning the CER should be reviewed and updated whenever new information could affect the assessment of the device’s safety, clinical performance or benefit-risk profile.
The frequency of updates will depend on factors such as the device’s classification, risk profile, novelty, maturity and the amount of new clinical evidence generated through Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Manufacturers should define their review strategy within their Quality Management System and ensure that the CER remains aligned with the latest available evidence.
Events That May Trigger a CER Update
| Trigger | Why the CER Should Be Reviewed |
|---|---|
| New Post-Market Surveillance (PMS) data | Complaint trends, adverse events or customer feedback may affect the clinical evaluation. |
| PMCF findings | New clinical evidence collected after CE marking should be incorporated into the CER. |
| New scientific literature | Recently published studies may strengthen or challenge the existing clinical evidence. |
| Clinical investigation results | New study data should be critically evaluated and incorporated where relevant. |
| Design or manufacturing changes | Significant changes may alter the device’s safety, performance or intended purpose. |
| Risk Management updates | Changes to identified hazards or residual risks should be reflected in the benefit-risk assessment. |
| Field Safety Corrective Actions (FSCAs) | Safety-related corrective actions may require reassessment of the clinical evidence. |
| Changes to the intended purpose or claims | Any modification to the device’s intended use should be supported by an updated clinical evaluation. |
| Regulatory or State of the Art changes | New guidance, standards or accepted clinical practice may require the CER to be reviewed. |
Maintaining a Living Document
Manufacturers should have documented procedures describing how the Clinical Evaluation Report is maintained throughout the product lifecycle. Rather than rewriting the report from scratch each time, many organisations perform scheduled reviews that assess whether new evidence has emerged and whether it changes the overall conclusions of the Clinical Evaluation.
This ongoing approach helps ensure that the CER remains consistent with the Risk Management File, Technical Documentation, Post-Market Surveillance activities and any PMCF data generated after the device has been placed on the market.
Keeping the CER up to date not only supports continued compliance with the EU MDR but also demonstrates to Notified Bodies that the manufacturer has an effective process for monitoring the clinical safety and performance of the device throughout its lifecycle.
Need to Develop a Post-Market Clinical Follow-up (PMCF) Strategy?
Post-Market Clinical Follow-up (PMCF) provides the ongoing clinical evidence needed to confirm that a medical device continues to be safe, performs as intended and maintains an acceptable benefit-risk profile after CE marking. Learn how to develop compliant PMCF Plans, PMCF Evaluation Reports (PMCFERs), clinical data collection strategies and lifecycle monitoring in our Guide to Post-Market Clinical Follow-up (PMCF).
Common Clinical Evaluation Report Mistakes and How to Avoid Them
Preparing a Clinical Evaluation Report (CER) is more than compiling published studies or completing a regulatory template. A high-quality CER should present a logical, evidence-based assessment that demonstrates the medical device is safe, performs as intended and continues to achieve a favourable benefit-risk profile.
Many delays during conformity assessment arise because the CER lacks sufficient clinical justification or is inconsistent with other elements of the Technical Documentation. Identifying and addressing these issues early can significantly improve the quality of the submission and reduce the likelihood of additional questions from a Notified Body.
Frequent CER Deficiencies
| Common Mistake | Why It Causes Problems | Best Practice |
|---|---|---|
| Outdated clinical evidence | The CER no longer reflects current scientific knowledge or the state of the art. | Regularly review new literature, PMS data and PMCF findings. |
| Poorly documented literature searches | Reviewers cannot verify that all relevant clinical evidence has been identified. | Use a systematic, reproducible literature search strategy with documented inclusion and exclusion criteria. |
| Insufficient critical appraisal | Studies are summarised without assessing their quality, relevance or limitations. | Critically evaluate every evidence source and explain how it supports the overall conclusions. |
| Weak benefit-risk assessment | Clinical benefits are not adequately balanced against residual risks. | Clearly justify why the demonstrated clinical benefits outweigh any remaining risks. |
| Unsupported equivalence claims | Claims of equivalence do not satisfy EU MDR expectations. | Only rely on equivalent device data where technical, biological and clinical equivalence can be robustly demonstrated. |
| Inconsistencies across documentation | The CER conflicts with the Risk Management File, IFU, labelling or intended purpose. | Ensure all Technical Documentation presents a consistent description of the device and its clinical claims. |
| Failure to update the CER | The report no longer reflects current PMS, PMCF or vigilance information. | Maintain the CER as a living document and review it whenever significant new evidence becomes available. |
Building a High-Quality Clinical Evaluation Report
Manufacturers should approach the CER as a scientific evaluation rather than a regulatory formality. Every conclusion should be supported by objective clinical evidence, every assumption should be justified and every statement should remain consistent with the wider Technical Documentation.
A well-structured Clinical Evaluation Report should be:
- Scientifically robust and evidence based.
- Clear, logical and easy for reviewers to follow.
- Fully aligned with the device’s intended purpose and clinical claims.
- Consistent with the Risk Management File, GSPRs, labelling and Instructions for Use (IFU).
- Supported by current clinical evidence and an appropriately documented literature review.
- Regularly reviewed and updated throughout the device’s lifecycle.
By following a structured methodology and maintaining the CER throughout the product lifecycle, manufacturers can not only improve their chances of a successful conformity assessment but also demonstrate an ongoing commitment to patient safety, clinical performance and regulatory compliance under the EU MDR.
Need to Build a Complete EU MDR Technical File?
The Clinical Evaluation Report (CER) is just one component of your EU MDR Technical Documentation. Learn how to structure a complete Technical File, including the Device Description, GSPR Checklist, Risk Management, Verification and Validation, Biological Evaluation, Clinical Evaluation and Post-Market Surveillance documentation in our Guide to Structuring a Medical Device Technical File.
How Does Risk Management Support Your Clinical Evaluation Report?
A Clinical Evaluation Report should demonstrate that the clinical benefits of a medical device outweigh any residual risks. Discover how ISO 14971 risk management supports hazard identification, benefit-risk analysis, risk control measures and lifecycle monitoring, and how it integrates with Clinical Evaluation under the EU MDR in our Complete Guide to ISO 14971 Risk Management.
Conclusion
A Clinical Evaluation Report (CER) is far more than a regulatory document—it is the evidence-based justification that demonstrates a medical device is safe, performs as intended and delivers a favourable benefit-risk profile throughout its lifecycle. By systematically evaluating clinical evidence, manufacturers can show compliance with the EU MDR while supporting informed regulatory decision-making and protecting patient safety.
Preparing a high-quality CER requires more than collecting clinical data. Manufacturers should adopt a structured methodology, critically appraise all relevant evidence, document their conclusions clearly and ensure the report remains aligned with Risk Management, Technical Documentation, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
Because clinical evidence evolves over time, the Clinical Evaluation Report should be maintained as a living document. Regular reviews, supported by new literature, clinical investigations, PMS and PMCF findings, help ensure the CER continues to reflect the current state of scientific knowledge and demonstrates ongoing compliance with the EU MDR.
Whether you are preparing your first Clinical Evaluation Report or updating an existing CER for continued MDR compliance, investing in a robust, well-structured report will help streamline Notified Body reviews, reduce regulatory risk and support the long-term success of your medical device.
How Patient Guard supports clinical evaluation
Preparing a compliant CER requires both regulatory expertise and a strong understanding of clinical evidence.
Patient Guard supports manufacturers with:
- clinical evaluation strategy development
- CER writing and review
- Creation of the state of the art literature report
- systematic literature searches
- integration with risk management and PMS systems
- Notified Body submission preparation
This structured support helps ensure that clinical evidence aligns with EU MDR regulatory expectations.
Preparing for a Notified Body Review?
For Class IIa, IIb and III medical devices, the Clinical Evaluation Report (CER) is one of the most closely scrutinised documents during conformity assessment. Learn how Notified Bodies assess Technical Documentation, Clinical Evaluation, Risk Management, Post-Market Clinical Follow-up (PMCF), Quality Management Systems and overall EU MDR compliance in our Complete Guide to EU MDR Notified Bodies.
Frequently Asked Questions about MDR Clinical Evaluations
A Clinical Evaluation Report (CER) is a structured document required under the EU MDR that critically evaluates all relevant clinical evidence relating to a medical device. It demonstrates that the device is safe, performs as intended and that its clinical benefits outweigh any associated risks throughout its lifecycle.
Yes. Clinical Evaluation is a requirement for all medical devices placed on the European market under Regulation (EU) 2017/745 (EU MDR). Although the scope and complexity of the CER will vary depending on the device’s classification, intended purpose and risk profile, every manufacturer must demonstrate that sufficient clinical evidence supports their device.
The Clinical Evaluation Plan (CEP) sets out how the Clinical Evaluation will be conducted, including the objectives, methodology and evidence sources. The Clinical Evaluation Report (CER) documents the outcome of that process, presenting the clinical evidence reviewed, the critical appraisal performed and the conclusions reached.
A CER may include published scientific literature, clinical investigation data, Post-Market Clinical Follow-up (PMCF) findings, Post-Market Surveillance (PMS) data, registry information, vigilance data and, where appropriately justified, evidence relating to equivalent devices.
A CER should be reviewed regularly and updated whenever significant new clinical evidence becomes available. This may include new literature, PMCF findings, PMS data, design changes, clinical investigation results, regulatory updates or changes to the device’s intended purpose or benefit-risk profile.
Notified Bodies assess whether the Clinical Evaluation Report contains sufficient, current and scientifically robust clinical evidence. They also review the quality of the literature search, critical appraisal methodology, benefit-risk assessment, State of the Art review and consistency between the CER and the wider Technical Documentation.
In some cases, yes. For well-established or lower-risk devices, published literature may provide sufficient clinical evidence if it is relevant, current and appropriately appraised. However, manufacturers should assess whether additional evidence, including PMCF or clinical investigations, is necessary based on the device’s characteristics and the requirements of the EU MDR.
Common deficiencies include poorly documented literature searches, outdated clinical evidence, insufficient critical appraisal, unsupported equivalence claims, weak benefit-risk assessments, inconsistencies with Risk Management documentation and failure to update the CER as new clinical evidence becomes available.
Yes. Clinical Evaluation is a continuous process under the EU MDR. Manufacturers should review and update the CER throughout the product lifecycle to reflect new clinical evidence, Post-Market Surveillance activities, Post-Market Clinical Follow-up (PMCF) findings and any significant changes affecting the device.
Yes. Patient Guard provides comprehensive Clinical Evaluation services for medical device manufacturers, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), systematic literature reviews, clinical evidence appraisals, PMCF documentation and ongoing lifecycle updates. We work with manufacturers across all device classes to help demonstrate compliance with the EU MDR and support successful Notified Body submissions.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to Clinical Evaluation Reports (CERs) under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Provides the legal framework for Clinical Evaluation Reports through Article 61 and Annex XIV, including the requirements for planning, conducting, documenting and maintaining clinical evaluations throughout the medical device lifecycle. |
| European Commission | MEDDEV 2.7/1 Rev. 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies | Provides the established methodology for preparing Clinical Evaluation Reports, including literature searching, appraisal of clinical data, analysis of clinical evidence and report structure. Although published under the former Directives, relevant sections continue to be referenced under the MDR where consistent with current legislation and MDCG guidance. |
| Medical Device Coordination Group (MDCG) | MDCG 2020-5 – Guidance on Clinical Evaluation and Equivalence | Explains how manufacturers should demonstrate and document technical, biological and clinical equivalence when relying upon an equivalent device within a Clinical Evaluation Report. |
| Medical Device Coordination Group (MDCG) | MDCG 2020-6 – Guidance on Sufficient Clinical Evidence for Legacy Devices | Provides guidance on determining and documenting sufficient clinical evidence to support conformity with the MDR and the conclusions presented within a Clinical Evaluation Report. |
| Medical Device Coordination Group (MDCG) | MDCG 2020-13 – Clinical Evaluation Assessment Report Template | Provides the template used by Notified Bodies when documenting their assessment of a manufacturer's clinical evaluation and related evidence, offering valuable insight into the areas examined during conformity assessment. |
| International Organization for Standardization (ISO) | ISO 14155:2026 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice | Defines internationally recognised Good Clinical Practice requirements for designing, conducting, recording and reporting clinical investigations that may contribute clinical evidence to a Clinical Evaluation Report. |
Clinical Evaluation Report requirements continue to evolve through legislation, recognised standards and regulatory guidance. Manufacturers should always consult the latest published legislation, international standards and official guidance when preparing, updating and maintaining Clinical Evaluation Reports throughout the medical device lifecycle.
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