Webspecific claims are supported by specific pre-clinical and clinical data and risk analysis. † Verifying that the clinical evidence and the clinical evaluation are adequate and shall … Web6 The Manual should be read in conjunction with other documents providing guidance on classification, such as MDCG 2024-24 Guidance on classification of medical devices and MDCG 2024-16 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2024/746.

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