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CE-Marking Technical File

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A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.

The degree of complexity and need for prior review of this documentation by a Notified Body depends on the level of risk of the devices concerned.

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Core Value Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA…

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