Clinical Evaluation: What is a Clinical Evaluation Report (CER)?
Safety and efficacy of a medical device are the key capabilities that make sure the device is capable for the application for its intended use or intended purpose. With the increased stringency of regulations like the European Medical Device Regulation (MDR) and guidelines set by the U.S. Food and Drug Administration (FDA), the process of bringing a medical device to market has become more rigorous than ever.
A central activity for medical device manufacturers to demonstrate the safety and efficacy of their devices is the Clinical Evaluation which is documented in the Clinical Evaluation Report (CER). Thus, this document plays a critical role in gaining market access approval not only in Europe and the United States, since most countries have similar market access requirements or even mutual acceptance regulation for MDR or FDA conform medical devices.
Clinical Evaluation - What is it and who does it impact
Clinical evaluation involves the systematic assessment of clinical data pertaining to a medical device to verify its safety and performance. This evaluation is not a one-time event but an ongoing process throughout the device's lifecycle. It encompasses the collection, appraisal, and analysis of clinical data from various sources, including clinical trials, post-market surveillance, and scientific literature.
Clinical evaluation impacts various stakeholders within the medical device industry.
Manufacturers must conduct thorough clinical evaluations to obtain and maintain regulatory approval for their products. For manufacturers of medical devices, clinical evaluation is the core process for product design and realization result evaluation.
Regulatory bodies, such as the European Notified Bodies and FDA, rely on robust clinical evaluation data to assess the safety and effectiveness of medical devices before granting market authorization. As authorities they can oversee activities of manufacturers to provide safe and effective devices and assure public health.
Healthcare professionals can be sure the devices they want to use are performing according to their documentation and will be efficient for their intended purpose when handled accordingly.
Patients will benefit from the assurance that medical devices have undergone rigorous clinical evaluation to ensure their safety and efficacy so the health problem can be effectively served.
What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a comprehensive document that summarizes the results of the clinical evaluation process for a medical device. It provides a detailed analysis of the clinical data collected, along with an assessment of the device's safety, performance, and intended use. The CER serves as a critical tool for demonstrating compliance with regulatory requirements and supporting the marketing authorization of medical devices.
How to create a Clinical Evaluation Report?
Creating a Clinical Evaluation Report involves a systematic and well-defined process, which includes considering the role of the technological state-of-the-art and the interaction with product realization processes. Risk management is a key process of clinical evaluation and can be understood as the central process to include clinical evaluation information into the product lifecycle phases. Clinical evaluation can thus be seen as the final proof of risk management evaluation results and so the demonstration of the product's safety and performance capabilities. Here are the key steps:
Data Collection: Gather relevant clinical data from various sources, including literature review, clinical trials, post-market surveillance, and public reporting sources. Ensure the data is comprehensive, up-to-date, and relevant to the device under evaluation. Take into account the technological state-of-the-art and how it is met, incorporated or exceeded by the considered device and the resulting impacts on it's safety and performance. Make references to the technological state-of-the-art and equivalent devices for the intended purpose. If clinical data are not available as literature, they need to be created with clinical investigations, and from other sources for patient and user feedback, including public databases on feedback from medical devices.
Data Appraisal: Evaluate the quality and reliability of the collected clinical data. Assess factors such as study design, patient population, endpoints, and statistical analysis to determine the strength of the evidence supporting the device's safety and performance. When using clinical data from available device studies, take into account the equivalence of those devices and the technological state-of-the-art and their impact on the interpretation of the data.
Risk Assessment: Conduct a thorough risk assessment to identify and mitigate potential hazards associated with the device's use. Evaluate factors such as device design, intended use, patient population, and clinical outcomes to assess the risk-benefit profile of the device. Consider the technological state-of-the-art and how much it is applicable in the device's design to evaluate and manage risks.
Clinical Evaluation: Analyze the collected data and risk assessment results to assess the device's safety, performance, and clinical effectiveness. Consider factors such as clinical outcomes, adverse events, patient satisfaction, and comparative effectiveness to draw conclusions about the device's clinical performance. Refer the technological state-of-the-art and the device design for benchmarking with existing solutions on the market.
Interaction with Product Realization Processes: Ensure that the clinical evaluation process is integrated with the product realization processes of the medical device company. This includes considering the technological state-of-the-art during the design and development stages, as well as incorporating feedback from clinical evaluation into future iterations of the device. The interaction between information from clinical evaluation and product realization processes should be seamless to ensure the device meets the necessary safety and performance requirements. The best means for integration of clinical evaluation information with product design and realization is risk management and a thorough comparison of the device design and outcome with the technological state-of-the-art for the intended purpose.
Document Preparation: Compile the findings of the clinical evaluation into a comprehensive Clinical Evaluation Report. Ensure the report is well-organized, clearly written, and supported by relevant data and analysis. Include details on the device's intended use, indications for use, clinical study results, risk assessment findings, and conclusions. Depending on the device classification, the CER must be updated regularly with information from post market surveillance. Post Market Surveillance reports must also demonstrate how feedback from the market was incorporated through risk management in product design or realization changes, and that resulting risks were evaluated accordingly regarding the devices safety and performance.
Review and Approval: Review the completed Clinical Evaluation Report internally to ensure accuracy, consistency, and compliance with regulatory requirements. Obtain any necessary approvals from regulatory authorities or notified bodies before submitting the report as part of the device registration or marketing application. Consider the feedback received during the product realization processes and incorporate it into the final report, if applicable.
Steps to Prepare Your Medical Device Company
Preparing a medical device company for the creation of Clinical Evaluation Reports requires careful planning and execution. Here are some essential steps to consider:
Define the intended purpose: the intended purpose or intended use of the medical device is the base for all regulatory evaluation steps. The sooner it is defined, the better work not only for clinical evaluation can be aligned accordingly. Since the scope of applicable regulations depends on the classification of the device according to its intended purpose, effort for product and process documentation and for clinical evaluation strongly vary with intended purposes of a medical device.
Establish a Regulatory Strategy: Develop a clear regulatory strategy that outlines the requirements for clinical evaluation and documentation based on the target markets and regulatory pathways for your medical devices. This strategy should include the identification and definition of clinical requirements and documenting them in a way that they can be referenced in detail. The regulatory strategy is based on the technological state-of-the-art and the intended purpose, and it can include considering the equivalence of devices on the market.
Build a Cross-functional Team: Assemble a multidisciplinary team with expertise in clinical research, regulatory affairs, quality management, and product development to oversee the clinical evaluation process and report preparation. This team should also be responsible for linking clinical risks to the corresponding clinical requirements.
Implement a digital Quality Management System (QMS): Implement a robust Quality Management System that encompasses procedures and processes for conducting clinical evaluations, documenting findings, and ensuring compliance with regulatory requirements. This system should facilitate continuous monitoring and updating of clinical requirements, evidence, and risk assessments throughout the product lifecycle. To ensure efficiency information about regulatory requirements and product lifecycle should be managed as single information items that keep detailled traceability and allow automated document creation using item selections.
Stay Informed: Stay abreast of changes to regulatory requirements, guidelines, and best practices related to clinical evaluation and reporting. Attend industry conferences, workshops, and training sessions to stay informed and up-to-date on evolving regulatory landscape. This includes staying informed about the latest clinical data sources and mapping them to specific clinical requirements. Also data from market feedback for equivalent devices should be referenced.
Invest in Training and Resources: Provide training and resources to your team members to enhance their understanding of clinical evaluation principles, methodologies, and regulatory requirements. Invest in tools and technologies that facilitate data collection, analysis, and reporting for clinical evaluations. This includes utilizing automated report generation to streamline the preparation of comprehensive Clinical Evaluation Reports (CERs).
Engage with Regulatory Authorities: Establish open communication channels with regulatory authorities and notified bodies to seek guidance, clarification, and feedback on clinical evaluation requirements and report submissions. Proactively address any questions or concerns raised by regulatory authorities to expedite the approval process. This includes ensuring facilitated regulatory compliance through clear traceability between clinical requirements, evidence, and risk assessments.
By following these steps and using an item-based approach for process and product documentation / information management, medical device companies can navigate the regulatory landscape with confidence and bring safe and effective devices to market for the benefit of patients worldwide.