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CE Marking Procedure

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The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745.

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CE Marking Procedure - Overview

The CE Marking Procedure provides detailed instruction on the creation, content and routine maintenance of CE Technical Documentation / Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with the Medical Device Regulation MDR (EU) 2017/745.

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