clinical evaluation of medical devices
TRANSCRIPT
Stages of clinical evaluation
Clinical evaluation is based on a comprehensive analysis of available pre-market clinical data relevant to the intended use of the medical device in question, including clinical performance data and safety data. This includes data specific to the device in question as well as any data relating to devices claimed as equivalent by the manufacturer. Main Stages of Clinical Evaluation are as follows: • Stage 01 - Identification of Clinical Data• Stage 02 - Appraisal of Clinical Data • Stage 03 - Analysis of Data www.i3cglobal.com
Clinical evaluation through literature review
Literature searching can be used to identify published clinical data. The data generated through literature searching may relate directly to the type of manufacture or to equivalent type of device. But these data help to establish acceptable performance and safety of a medical device. When conducting a literature review the team has to take care reasonable efforts to conduct a comprehensive search.
Published Clinical data is assessed with respect to its possible contribution and weighting in establishing both the performance of the device and its safety. Papers considered unsuitable for demonstration of performance because of poor study design or inadequate analysis may still contain data suitable for assessing the safety of the device.
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Clinical literature search
A literature search protocol is developed to identify and select the publications. The protocol should include the following:• The sources of data that will be used and a justification for their choice• The extent of any searches of scientific literature databases• The selection/criteria to be applied to published literature and justification for their
choice• Strategies for addressing the potential for duplication of data across multiple
publications• The literature search should be in English Language from reputed sources, peer
reviewed scientific journals in English Language. www.i3cglobal.com
Clinical literature search
The major literature searches can be extended to • Scientific databases• Research gate• The Cochrane Library• Clinical trial registers• Adverse event report databases- IRIS• Only official journals and books• Various national Regulatory Bodies www.i3cglobal.com
Clinical INVESTIGATION
The clinical investigation is a systematic investigation or study conducted in one or more human subjects to assess the safety and/or performance of a medical device. The manufacturer should conduct clinical investigation only in case the data from literature review and data from clinical experience are not enough to prove the conformity, safety and performance of device and sufficient similar products in the market which has same biological, clinical and technical characteristics from competitors are not there and existing literatures were not available to which it can be submitted for reference.
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