Regulatory Requirements
Medical Device Regulation (MDR)
Under the MDR, a clinical evaluation is required for all medical devices. The evaluation must be based on clinical data which provides sufficient clinical evidence to confirm compliance with relevant general safety and performance requirements.
In Vitro Diagnostic Regulation (IVDR)
The IVDR requires a performance evaluation, which is similar to the clinical evaluation required under the MDR. The performance evaluation verifies the scientific validity, analytical performance, and clinical performance of the IVD.
Clinical evaluation is a critical step in the regulatory process for both MD and IVD. It involves a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device to verify its safety and performance.
Clinical Evaluation
Artixio's Services for Clinical Evaluation
We help you ensure your medical device complies with all applicable regulatory requirements, including premarket approval, clinical trials, and quality management systems.
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Scientific Validity: The device must demonstrate a clear scientific validity, which is the scientific rationale for the intended purpose of the device.
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Clinical Performance: The device must demonstrate the ability to achieve the intended purpose as claimed by the manufacturer.
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Clinical Safety: The device must demonstrate safety when used as intended by the manufacturer. Any risks associated with the use of the device must be acceptable when weighed against the benefits to the patient.
We provide comprehensive clinical evaluation services, including:
Clinical Evaluation Plan (CEP)
We develop a systematic plan outlining the methodology for assessing the clinical safety and performance of your device.
The CEP is a comprehensive document that outlines the methodology for conducting the clinical evaluation. It includes:
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Device Description: A detailed description of the device and its intended purpose.
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State of the Art: A review of the current state of the art in medical science and technology related to the device.
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Identification of Pertinent Data: A plan for identifying and obtaining the necessary clinical data.
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Appraisal of Pertinent Data: A plan for appraising the relevance, quality, and reliability of the data.
Clinical Evaluation Report (CER):
We prepare a detailed report documenting the results of the clinical evaluation, demonstrating the safety and performance of your device.
The CER is a detailed report that documents the results of the clinical evaluation. It includes:
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Device Identification: Detailed information about the device, including its intended purpose and technical characteristics.
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Clinical Background: Information about the clinical background of the device, including the state of the art and the current standard of care.
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Methods: A detailed description of the methods used to identify, appraise, and analyze the clinical data.
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Results: The results of the clinical evaluation, including the conclusions drawn about the safety and performance of the device.
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Conclusions: The overall conclusions of the clinical evaluation, including an assessment of whether the device achieves its intended purpose without exposing patients to unacceptable risks.
Post-Market Clinical Follow-up (PMCF)
We design and implement PMCF studies to continuously collect and evaluate clinical data post-market.
PMCF is a continuous process that updates the clinical evaluation and risk management and feeds into the ongoing technical documentation updates. It’s an integral part of the clinical evaluation and is required under the MDR and IVDR. Here are the key components of PMCF:
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PMCF Plan: This is a detailed plan that outlines the methods and procedures for collecting and evaluating clinical data from the use of a device after it has been placed on the market. The PMCF plan includes the rationale for the PMCF; the methods and procedures for data collection and analysis; and the indicators and thresholds for risk.
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Data Collection: This involves the systematic collection of data about the safety and performance of the device in a real-world setting. Data can be collected through various means, including clinical studies, registries, and surveys.
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Data Analysis: The collected data is then analyzed to assess the continued safety and performance of the device, and to identify any need for preventive, corrective, or field safety corrective actions.
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PMCF Report: This is a detailed report that documents the methods, results, and conclusions of the PMCF. The report should provide an update of the benefit-risk determination, the main findings, and the conclusions of the PMCF.
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Update of the Clinical Evaluation and Risk Management: The results of the PMCF are used to update the clinical evaluation and risk management. This may lead to a revision of the instructions for use, and/or additional training for users.
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