Clinical Evaluation Report (CER) in Medical Device Regulation
A Clinical Evaluation Report (CER) is a vital document for obtaining CE marking in Europe, serving to assess the safety and performance of a medical device by compiling clinical data from various sources. This data, essential for compliance, can be gathered through literature reviews, clinical investigation studies, post-market surveillance data, and information from equivalent devices already on the market. CER writing demands in-depth knowledge of the product, including its mechanism of action, attributes, scientific validity, associated risks, adverse events, precautions, and contraindications. For an effective CER, often guided by MDCG clinical evaluation guidelines, manufacturers may refer to a clinical evaluation report example for insights. CER development typically begins in the design and development phase and requires a qualified evaluator, whose hiring must be justified as per MEDDEV Section 6 requirements.
How to Prepare a Clinical Evaluation Report for Medical Device?
A Clinical Evaluation Report involves four main steps:
- Clinical Evaluation Plan (CEP): The Medical Device Manufacturer begins by creating or updating the CEP. This plan sets the scope and outlines the approach for the clinical evaluation, defining how the clinical data will be collected and assessed.
- Data Identification: In this stage, the manufacturer gathers all pertinent clinical data for the medical device, including information from clinical investigations, Post-Market Surveillance (PMS), with a focus on Post-Market Clinical Follow-up (PMCF), scientific literature, and clinical data from equivalent devices. Analyzing gaps in clinical evidence can be challenging for many medical device manufacturers. Using a clinical evaluation report sample or adhering to a standardized clinical evaluation report format can streamline this process, ensuring accurate and comprehensive documentation of clinical data.
- Data Appraisal: Once the clinical data is gathered, it is evaluated for relevance, quality, and scientific validity. If there are any gaps in the evidence, new clinical data has to be generated to fill those gaps and ensure a comprehensive evaluation.
- Evidence Articulation: The final step requires the medical device manufacturer to ensure sufficient clinical evidence is available to meet each relevant General Safety and Performance Requirement (GSPR) for the medical device. Utilizing a well-structured clinical evaluation report template is essential for this process, as it helps streamline the preparation of the CER medical device, ensuring compliance with EU MDR standards.
While Drafting CER, it is essential to cover below information in Report
- Basic Information: Include the Medical device name and manufacturer’s name.
- Device Description: Provide a clear description of the device and its intended purpose.
- Claims Outline: Detail the therapeutic or diagnostic claims supported by data.
- Clinical Benefits: Describe the clinical benefits and associated outcome measures.
- State of the Art: Include a comparison of the benefits and risks of alternatives to the device.
- Clinical Data Summary: Summarize and Appraise the clinical data collected.
- Data Analysis: Analyze the data to demonstrate conformity with GSPR, focusing on performance, safety, and the benefit-risk ratio.
- Conclusions: Provide clear conclusions based on the clinical evaluation.
- Evaluator Qualifications: List the qualifications of the evaluators conducting the CER.
A well-prepared Clinical Evaluation Report (CER) is crucial for meeting regulatory compliance under the MDR CER requirements. By incorporating the necessary elements and following the outlined steps, manufacturers can effectively demonstrate the safety and efficacy of their medical devices. Utilizing a clinical evaluation report template simplifies the process, ensuring accuracy and completeness. For better understanding, reviewing a clinical evaluation report sample can provide valuable insights into structuring and presenting your CER effectively.
Points to keep in Mind while Preparing Clinical Evaluation Report
In accordance with MDR regulations, it is essential to maintain up-to-date Post-Market Surveillance (PMS) or Post-Market Clinical Follow-up (PMCF) data to ensure the continued safety and effectiveness of your medical device. PMCF is a continuous process that involves actively collecting and analyzing clinical data from a device already CE marked. This data helps in updating the clinical evaluation and supports the ongoing assessment of the device’s performance. For guidance, a clinical evaluation report example can be used to understand the necessary structure, while the clinical evaluation report format ensures consistency in presenting the collected data.
Updates to the CER may be necessary if any new Post-Market Surveillance (PMS) or PMCF data is discovered that could impact the current evaluation or its conclusions. This includes making sure the medical device CER reflects the latest clinical data and findings.
You can download the updated MEDDEV 2.7/1 Rev 4 updated in June 2016 guidelines, which offer comprehensive instructions on conducting a clinical evaluation for medical device manufacturers. These guidelines are essential for ensuring compliance with directives 93/42/EEC and 90/385/EEC. Following the MDCG clinical evaluation framework will help manufacturers meet regulatory requirements, supporting the successful certification of their medical devices.
Structure of a Clinical Evaluation Report
The structure of a Clinical Evaluation Report (CER) for medical devices is pivotal in ensuring regulatory compliance and demonstrating the safety and performance of the device. A well-structured CER medical device should begin with essential details such as the device name, manufacturer, and intended purpose. It should then provide a comprehensive review of the clinical data, including scientific literature, clinical investigations, and Post-Market Surveillance (PMS) data. The CER must also include an analysis of the benefit-risk ratio, drawing conclusions on the device’s overall safety and effectiveness. The report should conclude with the qualifications of the evaluator and any necessary evidence supporting the device’s compliance with General Safety and Performance Requirements (GSPR). A structured and comprehensive clinical evaluation report for medical devices plays a critical role in obtaining CE marking and ensuring market readiness.
Clinical Evidence in CER
Clinical evidence plays a crucial role in the Clinical Evaluation Report (CER) process for medical devices, ensuring they meet safety and performance standards under the EU MDR. The evidence must be gathered from reliable sources, such as clinical investigations, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) data. The evaluation of this clinical data is necessary to establish a medical device’s compliance with the General Safety and Performance Requirements (GSPR). To meet MDR clinical evaluation standards, manufacturers must ensure their CER incorporates comprehensive, high-quality evidence that supports the device’s safety, efficacy, and intended use. Effective clinical evidence analysis contributes significantly to successful CE marking.
What happens to a CER after completion?
Once a Clinical Evaluation Report (CER) is completed, it undergoes a thorough review to ensure that all required data and assessments align with regulatory requirements, particularly the EU MDR standards. After completion, the CER is submitted as part of the technical documentation for CE marking, supporting the device’s safety and efficacy claims. If new clinical data becomes available, the CER may require updates to reflect ongoing Post-Market Surveillance (PMS) or Post-Market Clinical Follow-up (PMCF) findings. The MDCG clinical evaluation report guidelines offer essential instructions for maintaining the CER’s accuracy and compliance throughout the device’s lifecycle. Continuous monitoring ensures that the Clinical Evaluation Report CER remains valid as long as the product is on the market.
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Looking for a template to guide you prepare your Clinical Evaluation Reports (CER) in-house? Buy once and use it for multiple product CER writing. These Clinical Evaluation Report (CER) templates are in compliance with MEDDEV 2.7/1 Rev 4, EU MDR, applicable MDCG guidelines.
