Clinical Evaluation
EU Medical Device Regulation 2017/745 (EU MDR)
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze & assess the clinical data pertaining to a device in order to demonstrate the safety and performance, including clinical benefits, of the device when used as intended. Clinical evaluation is required under Article 61 and Annex XIV of the European Medical Device Regulation 2017/745 (EU MDR).
This process involves evaluating the available clinical evidence, such as clinical studies, clinical literature and pre-clinical data to demonstrate that the device is safe and effective for its intended use in line with the generally recognized state of the art (SOTA). The clinical evaluation report is an output that summarizes the results of the clinical evaluation process and is used to support the device’s conformity with the EU MDR. The report must be updated regularly throughout the device’s lifecycle to ensure continued compliance with the EU MDR and forms part of the holistic technical documentation for the device.
The clinical evaluation process typically includes the following key documents:
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Clinical evaluation procedure
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Clinical evaluation plan (CEP)
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Literature search protocol & report for SOTA and device and
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Clinical evaluation report (CER)
The clinical evaluation procedure describes the relevant processes and responsibilities defined by the manufacturer to meet the expectations of EU MDR and relevant state of the art guidance.
Key Points:
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State of the art (SOTA) is heavily scrutinized during notified body review. A thorough review of the clinical background, medical conditions, guidelines/standards, current medical practice, alternative therapies, similar devices, benchmark devices, SOTA benefit-risk analysis and benchmarks of safety and performance are expected to be provided.
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Clinical claims for the subject device must be specified in the CER and supported with sufficient clinical data
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Clinical benefits shall be defined for every device and linked to appropriate measurable performance outcomes. The clinical benefit should reflect the intended purpose of the device
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Safety and performance outcomes should be quantitative and patient relevant established from benchmark values obtained from the state of the art literature review
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Choosing the correct clinical strategy is key under EU MDR. Whether the device can claim equivalence, well-established technology, clinical data not deemed appropriate (Art 61(10), or sufficient. The subject device will dictate the quality and quantity of clinical evidence required
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Process and Templates Development
Gap Assessment
Implementation
Continuous update of documentation