What is a Clinical Evaluation?
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1. Introduction of a Clinical Evaluation
- Clinical Evaluation is a process of collecting and assessing of clinical data relating to a medical device to verify the safety, effectiveness and performance and demonstrate conformity to the relevant regulatory requirements.
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2. When is a Clinical Evaluation needed?
- Clinical evaluation is a process conducted throughout the life cycle of a medical device. The first time when the manufacturers need to undertake the Clinical Evaluation is during the development of a medical device in order to identify data needed to be studied. After that the Clinical Evaluation should be repeated periodically as the new information regarding the safety, effectiveness and performance of this device is obtained during its use in a form of post marketing surveillance report(PMSR) or adverse event reports(AER).
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3. A Clinical Evaluation conducting process :
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STAGE 00 : Scope
- Define the scope, plan the Clinical Evaluation
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STAGE 01 : Identify pertinent data from
- literature searching and/or
- clinical experience and/or
- clinical investigation
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STAGE 02 : Appraisal of individual data sets
- suitability
- contribution of results to demonstration of safety, clinical performance and/or effectiveness
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STAGE 03 : Analysis of relevant data
- strength of overall evidence
- conclusions about safety, clinical performance and/or effectiveness
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STAGE 04 : Clinical Evaluation Report
- If clinical evidence sufficient to be able to declare conformity with relevant Essential Principles, a Clinical Evaluation Report (CER) is produced. If not additional or new clinical data are needed to be generated.
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