Can Anyone Write a Clinical Evaluation Report?

You Must Read This If You Work in the Medical Device Industry

No, not just anyone can write a Clinical Evaluation Report (CER) for a medical device. The integrity and reliability of a CER depend heavily on the qualifications and experience of its authors.

Given the complexities involved in assessing medical devices—particularly concerning patient safety, performance, and regulatory compliance—specific expertise is required.

👇 Here’s what you need to know about the qualifications that make someone eligible to undertake this critical task:

Qualifications and Experience Requirements:

According to MEDDEV 2.7/1 rev 4, a comprehensive outline details the qualifications and skills essential for individuals or teams tasked with conducting clinical evaluations of medical devices:

The requirements emphasize a combination of educational background and practical experience related to the specificities of the device under review. Let’s break it down:

1. Educational Background and Professional Experience:

   • Higher Education and Experience: Evaluators should possess a degree from higher education in a relevant field along with at least five years of professional experience. This combination ensures that the evaluator not only has foundational knowledge obtained through formal education but also practical experience in the field.

   • Extensive Professional Experience: If the evaluator does not have a formal degree, then a substantial ten years of documented professional experience in the relevant field is required. This provision allows for individuals who may have entered the field through non-traditional paths but have accumulated significant hands-on experience.

2. Specific Skills and Knowledge:

   • Research Methodology: Evaluators must understand clinical investigation design and biostatistics. This knowledge is crucial for designing studies that correctly assess the device and interpreting statistical results from clinical data.

   • Information Management: Experience with managing and retrieving information from relevant medical and scientific databases (like Embase and Medline) is necessary. This skill ensures evaluators can effectively gather and analyze existing research and clinical data pertinent to the evaluation.

   • Regulatory Requirements: Knowledge of the regulatory landscape governing medical devices is essential. Evaluators must be familiar with the standards and regulations to ensure the CER complies with all legal and regulatory requirements.

   • Medical Writing: Experience in medical writing, systematic reviews, and clinical data appraisal is important. This skill set helps in accurately documenting the evaluation findings and ensuring that the CER is clear, comprehensive, and scientifically robust.

3. Device-Specific Competence:

   • Device Technology and Application: Evaluators should have specific knowledge related to the technology of the device being evaluated and its clinical applications. This is important to assess whether the device performs as intended and to identify any potential issues with its use.

   • Diagnosis and Management Knowledge: Knowledge of the diagnosis and management of conditions the device is intended to treat, manage, or diagnose is required. Evaluators should also be aware of other medical alternatives and the standard treatment protocols to accurately position the device within the current medical practice landscape.

4. Justification of Evaluator Selection:

   • The manufacturer must be able to justify the choice of evaluators by documenting their qualifications and experience relative to the device under evaluation. This documentation is crucial not only for regulatory purposes but also for maintaining transparency and credibility in the evaluation process.

5. Declaration of Interest:

   • A declaration of interest for each evaluator must be presented. This is to ensure that there are no conflicts of interest that could bias the evaluation. The declaration must detail any potential financial, professional, or personal interests that the evaluators may have in relation to the device or its manufacturers.

6. Flexibility and Documentation:

   • The level of expertise required can vary in certain circumstances; however, any deviations from the standard requirements must be thoroughly documented and justified. This flexibility allows for the practical application of these guidelines while ensuring that any exceptions are transparent and rational.

Is a Medical Doctor Necessary for your Clinical Evaluation Team?

A common question asked is whether a medical doctor is necessary on teams writing and reviewing Clinical Evaluation Reports (CERs) for medical devices.

While medical device regulations and guidance documents don't explicitly require a medical doctor, the need often depends on the device's risk level:

Low-Risk Devices: For devices deemed low-risk and commonly used in standard medical care, evaluators with a general medical background are typically sufficient. Their foundational knowledge adequately equips them to assess these devices, where technological complexity and associated risks are relatively minimal.

High-Risk Devices: Conversely, evaluating high-risk devices requires evaluators with specialist medical expertise. This expertise is usually defined as having a medical degree, mainly if one is a medical doctor, which is relevant to the device's intended use. Such high-level expertise is crucial due to the intricate nature of these devices and their significant potential impact on patient health.

Medical doctors offer a depth of clinical experience and a comprehensive understanding of patient care dynamics, essential for accurately assessing the safety and effectiveness of sophisticated medical technologies. Their training allows them to critically analyze clinical data, understand complex device mechanisms, and assess the nuanced implications for various patient populations.

It is generally expected that at least one evaluator or author involved in the CER of a high-risk device will possess this type of specialist medical competence.

Now, Let's Dive Into How Declarations of Interest Are Created:

According to Appendix 11 of MEDDEV 2.7/1 rev 4, here is the detailed process:

You might wonder why declarations of interest are so crucial regarding Clinical Evaluation Reports (CERs) for medical devices.

Transparency about potential conflicts of interest is essential. As an evaluator, this ensures that your assessments are trusted and considered unbiased, upholding both their validity and integrity. This transparency is critical in ensuring that the notified body can trust the evaluation process.

What Needs to Be Disclosed:

1. Scope of Disclosure:

   • As an evaluator, you must disclose any relationships or interests that could potentially influence your evaluation results. This isn’t limited to apparent financial interests but also includes affiliations with manufacturing companies or personal relationships that could impact your impartiality.

2. Details to Include in Your Disclosure:

   • Financial Interests: This encompasses all financial ties, such as earnings, benefits, stock ownership, and any funding from entities that might gain from your evaluation findings.

   • Employment and Advisory Roles: You must disclose whether you’re currently in a role or have past positions that might influence your judgment. This includes both full-time and part-time positions, as well as any advisory capacities you might hold.

   • Intellectual Property Rights: If you have any patents, copyrights, or other intellectual property interests that the device’s evaluation might affect, these need to be clear.

   • Family and Personal Connections: It’s also important to consider your personal connections. Any significant financial or professional relationships involving your family members or close associates that could skew your objectivity must be disclosed.

3. How to Formalize Your Declaration:

   • Documenting and Updating Your Declaration: It must be written, signed, and dated to confirm its accuracy. Remember to update it annually or whenever a significant change occurs in your circumstances that might affect your impartiality.

   • Manufacturer’s Responsibility: It's up to the manufacturer to collect and maintain these declarations. They need to ensure that these documents are easily accessible for regulatory reviews whenever needed as part of the compliance and oversight measures.

Overall Conclusion

Thank you for joining me in exploring the crucial role of evaluator qualifications and declarations of interest in clinical evaluations. These elements are vital for maintaining the highest standards of integrity and patient safety in the medical device industry.

Next time, I'll start a series on how to create a state-of-the-art review, providing you with practical steps and insights to enhance your evaluations. Stay tuned for these upcoming editions, and feel free to share this newsletter with peers who might find it helpful.

Warm Regards,

Hatem ✌️