If you've never completed a medical device clinical evaluation report, you're probably concerned with how involved the report needs to be and how many resources you'll use to complete it. The updated European Medical Device Regulation (MDR) introduced in May 2017 has new, stricter criteria for CER reports.
As you might imagine, the level of detail contained in a CER depends on the device. A device with more significant potential patient risks requires a more in-depth CER report. The more that is at stake, the more detailed the report will need to be. But, no matter how many resources are required to complete a CER report, the structure remains the same.
We’ll show you what the essentials are for a clinical evaluations report. By understanding the requirements for a medical device CER, you’ll be able to plan ahead and accurately commit enough resources to finalize it efficiently.
6 Requirements of a Clinical Evaluation Report for Medical Device Manufacturers
A clinical evaluation report is a comprehensive analysis of pre-market and post-market clinical data relevant to a medical device. A detailed CER report must back any medical device approved for sale in Europe. The report should include an analysis of clinical performance and clinical safety. There are four discrete stages to perform a clinical evaluation of a medical device.
Stage 0: Scope and plan
Identify the scope of the medical device and the CER report and create a plan for the clinical evaluation.
Stage 1: Identification of pertinent data
Identify relevant pre-market and post-market clinical data.
Stage 2: Appraisal of pertinent data
Appraise each identified data set for scientific validity, relevance to clinical evaluation, and weight to the final report.
Stage 3: Analysis of the clinical data
Reach conclusions about the device’s compliance with essential requirements for safety and performance. The data analysis should include:
- Benefit/Risk Profile
- Residual Risks
- Uncertainties or Unanswered Questions
Stage 4: Finalize the report
After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be approved for sale in European markets.
Medical device manufacturers are required to provide a CER for European approval, and similar reports in other global markets. For example, the US FDA requires premarket approval (PMA) annual reports from medical device manufacturers. The responsibility is on the manufacturer to summarize clinical data on device performance for agencies or notified bodies. While the details of an effective report vary depending on the type of device manufactured, the architecture of an effective CER report is the same.
RELATED READING: The EU Medical Device Regulation Timeline: What You Should Know
The summary is a high-level overview of the CER report for external audiences at agencies or notified bodies. This section should summarize the:
- Benefit/Risk Profile
- Intended Target Groups
- Medical Indications
In addition to providing a summary of those insights, the summary should briefly address how your manufacturing organization concluded that the device has an acceptable benefit/risk profile based on the "state of the art" medical evidence and research.
The Scope section of a CER report is designed to be a highly comprehensive assessment of the devices discussed in the CER, including the technical and clinical aspects of the device. This section should clearly explain how the device works and the technologies used. The Scope section of a report may be very long for highly innovative devices or devices which use sophisticated technologies. It should:
- Identify the device(s), including products, models, sizes, accessories, and software versions if applicable.
- Name the manufacturer and include the manufacturing organization’s address.
- Provide a “concise” physical and chemical description of the device and materials
- Address whether the device uses pharmaceuticals, tissues, or blood products.
- Address device “mechanical and physiochemical characteristics,” such as sterility and radioactivity.
- Include a picture or diagram of the device.
- Describe whether the technology is new, a new application of existing technology, or an innovation.
- Address innovative aspects of the device
- Classify the device by group.
- Describe how the device achieves its intended purpose
- Position the device in the context of available options for clinical care
- Provide a precise description of the device’s intended purpose
- Classify target users, including medical indications, clinical form, stage, and symptoms.
- Delve into the intended application, such as single-use, non-invasive, duration of use.
- Identify the organs, tissues, or body fluids the device comes into contact with.
- Describe any precautions that are included with the device.
- Provide manufacturer’s claims on clinical performance and safety
- Explain whether the device is CE marked, market-approved, and regions in which it is sold
- If applicable, describe sales volumes
- Address any changes to the device or major events since the last CER report
3. Clinical Background
The clinical background section of a CER report is designed to be a heavily research-driven summary of the clinical context that surrounds the medical device. Authors should provide an overview of a literature review to give the reviewers an understanding of state of the art for the medical device being reviewed. The clinical context should be heavily detailed and address:
- Search methods
- Selection criteria for the literature review
- Quality control measures
- Number and type of research literature
In addition to a clear description of how the clinical background sources were selected, this section should address any applicable standards or guidance which impact the device. It should describe how the device fits into patient care by explaining how it fits into a state-of-the-art medical care setting:
- Describe the medical conditions treated
- Explain whether there are multiple clinical forms or severities of that condition
- Address how frequently the condition occurs in the general population, including demographics
- Provide insight into available options for managing and treating the condition
- Delve into the benefits and risks of available therapeutic options
- Address whether the device presents any hazards
- Explain who would be using the device in a clinical setting
For some medical devices, such as a tongue depressor, the clinical background section may be quite short and to-the-point. If you are marketing a medical device which treats a highly niche or complex health condition, this section may be significantly longer.
4. Device Under Evaluation
The device under evaluation section is designed to not only describe the device, but also describe the methods used for the CER and the data analysis. It should include several components, including a basis for the clinical evaluation, a demonstration for equivalence (if applicable), and the clinical data sets used. This section must address whether the clinical evaluation is based on scientific literature and justify equivalence if clinical data is not appropriate for the device.
If the CER report includes clinical data and analysis, the evaluation must address:
- Clinical data sets held by the manufacturer
- Clinical data from the literature review
- Summary and appraisal of clinical data sets for inclusion, including feasibility and weighting
This section should also include a comprehensive analysis of the clinical data involved, and a justification of the conformity assessment with regards to device risks and condition risks. It should consist of a benefit/risk profile, performance requirements, and address whether any side-effects are justified based on clinical outcomes and data.
RELATED READING: 4 Regulations That Apply to Medical Device CRO Selection
The basis of the CER conclusion is a clear statement which justifies that the device complies with essential requirements for patient safety. It should address the benefit/risk profile developed during clinical data analysis and draw from current knowledge to present whether the device and any associated risks are superior to medical alternatives.
In addition to a clear statement on compliance, the conclusions should touch on:
- Adequacy of manufacturer information materials
- Adequacy of intended purpose and risk reduction guidance
- Device suitability for intended users
- Sufficiency of manufacturer claims
The conclusion should compare the clinical data analysis reports with the manufacturer's safety claims, information materials, and the clinical-state-of-the-art for treating the intended condition to determine whether these materials are consistent or there are discrepancies. The conclusion should also address any residual risks or unanswered questions, and create a case for CE-marking if there are questions. If the clinical data analysis was inconclusive, or there are residual risks, the conclusion should address ongoing research and safety activities.
6. Dates and References
The final section of the report operates slightly similar to an appendix in an academic paper. It should include the following:
- Date of the next clinical evaluation
- Date of the current clinical evaluation
- A signed statement from the evaluator
- Final release data from the manufacturer
- Evaluator Qualifications
Writing a Highly Effective CER Report
The complexity of a CER can vary significantly, but the outcome should be the same. The resulting report should be able to be read and understood by a third party at an agency or notified body. It should include sufficient detail for understanding the data, analysis, and all conclusions reached to demonstrate device safety for sale in European markets.
The length and effort required to create a CER report can vary significantly depending on many factors, including the device being evaluated. If you can skip clinical data analysis by making a strong case for equivalency, it may be significantly less complicated. In any setting, the CER must address the sections described above and build a strong case for patient safety based on device quality.