In the EU clinical evaluation is required for every medical device placed on the market for which no clinical investigation has been conducted.
In the United States analysis of the clinical data available for the predicate device (the device previously approved by the FDA and used as a benchmark for your product) is a part of 510(k) or PMA product dossiers. This analysis can be considered as an equivalent of the Clinical Evaluation in the EU.
Some countries have no clear standards on Clinical Evaluation. However, they require collection and analysis of pre-market clinical data as a part of regulatory submission. Mostly these countries accept Clinical Evaluations that conform to the European requirements.
In the EU clinical evaluation is required for every medical device placed on the market for which no clinical investigation has been conducted.
In the United States analysis of the clinical data available for the predicate device (the device previously approved by the FDA and used as a benchmark for your product) is a part of 510(k) or PMA product dossiers. This analysis can be considered as an equivalent of the Clinical Evaluation in the EU.
Some countries have no clear standards on Clinical Evaluation. However, they require collection and analysis of pre-market clinical data as a part of regulatory submission. Mostly these countries accept Clinical Evaluations that conform to the European requirements.
Clinical Evaluation is based on existing scientific and clinical data. The European Medical Device Vigilance System guidance MEDDEV 2.7.1. rev. 4 can be used as a standard for Clinical Evaluations.
Clinical Evaluation is based on existing scientific and clinical data. The European Medical Device Vigilance System guidance MEDDEV 2.7.1. rev. 4 can be used as a standard for Clinical Evaluations.
Clinical evaluation is not a one-off event but a process that is a part of your Post Market Surveillance System. Manufacturer's post-market clinical follow-up procedures should be in place and the product's Clinical Evaluation should be regularly updated.
Clinical evaluation is not a one-off event but a process that is a part of your Post Market Surveillance System. Manufacturer's post-market clinical follow-up procedures should be in place and the product's Clinical Evaluation should be regularly updated.
Clinical Evaluation should be conducted by people who have experience working with scientific and clinical data. It is important not only how the evaluation is performed but also who performs it. The person who carries out your Clinical Evaluation should be qualified to do that and able to demonstrate his/her qualification. Biographical information of the evaluator has to be attached to evaluation reports, placed in the Technical File and if required submitted to the regulatory authorities.
Clinical Evaluation should be conducted by people who have experience working with scientific and clinical data. It is important not only how the evaluation is performed but also who performs it. The person who carries out your Clinical Evaluation should be qualified to do that and able to demonstrate his/her qualification. Biographical information of the evaluator has to be attached to evaluation reports, placed in the Technical File and if required submitted to the regulatory authorities.
We have experience conducting clinical evaluations for tens of medical devices. We will be glad to help you perform evaluations of your products.
We have experience conducting clinical evaluations for tens of medical devices. We will be glad to help you perform evaluations of your products.
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