Clinical evaluation or investigation?
For devices undergoing clinical investigation in the European Union, manufacturers must comply with the requirements of the Medical Device Directive. In certain Member States, the Competent Authority reserves the right to perform a pre-assessment of clinical information together with a technical review of the proposed device. Inadequacies in these submissions remain the single most common reason for rejection.
O'Connor
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Quality First International Ltd, Southport, UK. qfi@tour.demon.co.uk
D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005069:Evaluation Studies as Topic; D006801:Humans; D012107:Research Design / Q000592:standards