The clinical evaluation report (CER) is crucial for medical device approval in most countries. It is a comprehensive report summarising the device’s safety, performance, and effectiveness based on clinical data. The CER plays a vital role in ensuring the medical device’s safety and efficacy, and any errors or omissions in the report can have serious consequences.
The problem is clinical evaluation reports aren’t always easy to write or summarise—they’re long and dense with information that needs to be conveyed clearly and concisely. So, it’s unsurprising that mistakes are made more often than we’d like.
Knowing which mistakes you are most likely to make certainly helps us to avoid them! So, let’s explore some of the most common mistakes one makes while creating and writing CER.
Why You Need to Get the CER Right
A CER provides regulatory authorities with an overview of the device and its clinical use, allowing them to assess its risks and benefits. Therefore, it is essential for manufacturers to conduct a thorough and unbiased evaluation of their device and its clinical data and to provide this information transparently and objectively in the CER.
Failure to provide an accurate and comprehensive CER can result in rejection and, most definitely, delays. However, incorrect CER can also result in the wrong or improper use of the device, potentially putting patients at risk.
Main Elements of a Clinical Evaluation Report
The key to avoiding mistakes in CER is to follow the guidance documents and use the clinical evaluation plan as a guide. The MDCG 2020-13 is an excellent place to start your CER process, as you want to review what is expected from your organization in CER before actually writing the report.
According to the current info, the critical stages of CER writing are as follows:
Stage 0: Scope
Before you do anything else, the scope of the clinical evaluation has to be defined. Then, the clinical evaluation plan is developed, which includes identifying the intended use and the indications for the use of the device, defining the patient population, and establishing the clinical endpoints that will be used to assess the device’s safety and effectiveness.
Stage 1: Clinical Data
After the plan is made and you have all the details sorted out, the next step is finding the clinical data that will be used to support and evaluate the medical device. Clinical data comes from many sources, including data from clinical trials, post-market surveillance, published literature, and third-party studies on equivalent devices in the market.
Stage 2: Appraising the Amassed Data
After you have collected enough clinical data to support your device, the quality, and reliability of the data will have to be assessed, and any potential biases or limitations identified. The theme of the clinical data should also match the key questions established in Stage 0. The previous stage and this stage are where you do the literature review.
Stage 3: Data Analysis
The last step analyzes the collected evaluation findings before writing the clinical evaluation report. The data is evaluated in the context of the intended use and patient population, and any potential risks or benefits are assessed. The data analysis may include statistical analysis, meta-analysis, and other methods to quantify the device’s effectiveness.
Stage 4: Clinical Evaluation Report
The next obvious step is documenting the clinical evaluation in a report. The report should include a brief executive summary of the reviewed clinical data, the data analysis results, and any conclusions regarding device safety and performance. The report should also discuss any limitations or uncertainties in the data and any further testing or evaluation recommendations.
Common Clinical Evaluation Report Mistakes
1. Insufficient Literature Review
The literature review is, arguably, the key component of most evaluation reports. Unfortunately, when the literature review is comprehensive or accurate, the clinical data analysis is incomplete or flawed, two factors which can lead to inaccurate conclusions about the medical device’s safety and effectiveness.
Missing key research can result in missed safety signals or adverse events associated with the medical device. Also, it cuts down your work for clinical trials and tests while giving you an edge if you want to provide upgraded tech over others in the market.
2. Inadequate Evaluation of Clinical Data
Inadequate evaluation of clinical data can lead to incomplete or inaccurate analysis, resulting in errors or mistakes in the clinical evaluation report. Not to mention, if the evaluation of clinical data is inadequate, safety signals or adverse events associated with the medical device may be missed.
A lack of proper evaluation also means failure to identify alternative treatments or devices. This is also a significant part of the CER.
3. Lack of Clarity in The Report
Even if you manage to find all relevant clinical data, combining all evidence in one place in a manner that makes sense is an entirely different endeavor.
A lack of clarity in the report can result in a faulty clinical evaluation report. If the structure of the report is unclear or confusing, it is difficult to understand the findings or draw conclusions leading to a wrong interpretation of the data.
A disorganized CER cannot get the point across, which means it fails to meet the regulatory requirements—for example, notified bodies need clinical evaluation reports to be clear, concise, and transparent.
4. Failure to Address Risks and Safety Concerns
A CER’s primary objective in full report is to assess a medical device’s safety and performance. If risks and safety concerns are not adequately addressed in the report, it could lead to serious consequences, including injury or death.
5. Inconsistencies in The Report
Inconsistencies present in a CER can be a serious problem because they can undermine the report’s credibility. For example, there are discrepancies between the data presented in the report and other sources of information, such as clinical trial reports.
In that case, it may be difficult for regulatory bodies to determine the authenticity of all data. Naturally, delays in the approval or rejection processes of the device could occur next. Costing funds and time of the manufacturer.
6. Over-Reliance on Non-Clinical Data
Non-clinical data, such as data from animal studies, can help assess the safety and effectiveness of a medical device. However, if a CER relies too heavily on non-clinical data and does not include adequate clinical data, this can be a serious problem. Clinical data is often considered the gold standard in determining the safety and effectiveness of medical devices.
If there is insufficient clinical data in the report, regulatory bodies may refuse to grant approval for the device. Additionally, non-clinical data may not always be directly applicable to humans, so over-reliance on this data could result in the approval of a device that is ultimately unsafe or effective for human use.
Tips to Avoid Mistakes in Writing a Clinical Evaluation Report
So, now we know how the most common CER mistakes come to be. To prevent them, you need to do the opposite. To summarise, ensure to do the following things to avoid most CER mistakes.
- Conduct a comprehensive literature review.
- Ensure that clinical data is analyzed thoroughly
- Use clear and concise language
- Address risks and safety concerns effectively
- Maintain consistency throughout the report
- Use as much clinical data from recent sources as possible