Reviewing a CER: A Guide for Efficiency

By Sandra Gopinath, Chief Regulatory Officer at Mantra Systems Ltd.

Did you know that a single overlooked detail in your Clinical Evaluation Report (CER) could delay your medical device’s approval for months? In an industry where time is critical, and regulatory requirements are stringent, how can you ensure your CER not only meets the necessary standards but accelerates your path to market???

In this article, we’ll explore how to efficiently review a CER to ensure EU MDR compliance while streamlining your process.??

What Is a Clinical Evaluation Report??

A CER is an essential part of the technical documentation of medical devices to demonstrate conformity with the EU MDR. It provides a detailed evaluation of clinical data, including the results of clinical investigations, scientific literature, and post-market surveillance to demonstrate a medical device’s clinical performance and safety. In EU MDR terms, it explains how the device meets the general safety and performance requirements outlined in Annex I.?

What Are the Key Requirements for CERs Under EU MDR?

The first step in reviewing a CER is ensuring that it meets the requirements outlined in the EU MDR, particularly Article 61 and Annex XIV of the regulation. This includes:???

• Clinical Data: A CER must include sufficient clinical data to confirm the device's safety and performance. The data may come from clinical investigations, scientific literature, or post-market surveillance, but it must be relevant and sufficient for the device’s intended use and risk profile.?

• Clinical Evaluation Process: Manufacturers must plan, conduct and document a methodologically sound evaluation process. This should include a systematic and critical review of the clinical data collected from clinical investigations, scientific literature, or post-market surveillance (if available).?

• Risk-Benefit Analysis: The CER should carefully assess the risk-benefit profile of the device. The report should include a comprehensive analysis of the undesirable side effects of the device, along with a clear comparison of its clinical benefits against potential risks. The CER should outline any mitigation strategies employed by the manufacturer to minimise the risks associated with the device.?

• Equivalence: If the device under review is a modification of an already marketed product, the CER should provide clear evidence of equivalence with the original device. This includes demonstrating that the device under review is technically, clinically and biologically similar to the already marketed product to an extent that the differences between them do not impact the clinical performance and safety of the device.??

• Continuous Update: The CER is not a one-time document. It must be updated regularly throughout the lifecycle of the device to reflect updates in clinical performance, safety data, and any changes to the device's intended use. For high-risk devices (Class III or implantables), this is required annually.?

A well-prepared CER should be clear and comprehensive, containing thorough documentation that aligns with these regulatory expectations.??

A Guide to Reviewing a CER?

To ensure an efficient review of a CER, follow these key steps:?

Step 1: Preparation??

Before beginning the review, familiarise yourself with the device’s intended purpose, classification, claims, and previous clinical evaluations. Understanding the context will help you identify key areas of focus and set priorities for the review process.?

Step 2: Review the Clinical Data??

Carefully analyse the clinical data included in the CER, ensuring that it meets the required standards of scientific rigour. Develop a checklist outlining the key aspects to be evaluated. This ensures consistency and comprehensiveness throughout the review process.??

Consider the following:?

• Accuracy: Check the data presented in the CER is accurate and consistent with the source documents.?

• Study Design: Check the quality of the studies referenced—are they well-conducted, peer-reviewed, and applicable to the device’s intended use? Prioritise high-quality studies, such as randomised controlled trials (RCTs), when available.?

• Patient Population: Ensure the patient groups studied reflect the intended users of the device, with appropriate inclusion/exclusion criteria.?

• Endpoints: Verify that the clinical outcomes are clearly defined and aligned with the device’s intended claims. Evaluate the appropriateness of these endpoints in assessing the performance and safety of the device.??

Step 3: Optimise the Review Process??

The review itself can be streamlined for maximum effectiveness. First off, allocate sufficient time to review the clinical data. Rushing the review process can lead to overlooked issues and errors. Secondly, divide the CER into sections and assign reviewers with relevant expertise to each section if possible. This allows for a more focused and in-depth review. If you are reviewing the CER with other members of your team, leverage online platforms designed for review and collaboration. These tools will facilitate feedback sharing, version control, and tracking of comments. Thus, eliminating the chaos of multiple email threads and attachments.?

Step 4: Compliance with EU MDR?

Evaluate if the CER adheres to the specific EU MDR requirements and structure as outlined in Annex XIV. The CER should include sections on the device's intended purpose, clinical data sources, clinical evaluation process, risk management, and benefit-risk analysis.??

Check if the risk-benefit analysis of the report:??

• Discusses how the benefits of the device outweigh the risks.?

• Addresses any adverse events or incidents, including the manufacturer’s plans for mitigating these risks.?

• Cites appropriate clinical data to support claims of safety and performance.?

Identify any gaps in the clinical evidence or areas that require further investigation. Look for:?

• Insufficient data on certain patient populations or clinical indications.?

• Incomplete or outdated information that needs to be supplemented with new research or tests.?

Examine if all claims made in the CER are substantiated with evidence. Additionally, verify that all references to clinical data, literature, and clinical investigations are properly cited.?

Step 5: Post-Review Actions?

Consolidate feedback and hold a review meeting to discuss gaps and explore potential solutions. Establish a system for tracking the revisions made based on the feedback to ensure that all comments are addressed and that the CER is continuously improved.?

Conclusion?

While there’s no one correct way to review a CER, the strategies outlined in this article will help you to conduct efficient reviews, identify any gaps in evidence, and ensure timely updates. Remember, a well-planned and structured review will not only save time and resources but also ensure the quality and compliance of your CER.?

If you need expert assistance with reviewing CERs or technical files under the EU MDR, contact our team for a free, no-obligation discussion.?

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