Applying for EU CE certification for Class D medical devices involves several key steps. First, ensure your device meets the EU Medical Device Regulation (MDR) requirements. Then, you need to prepare a Technical File or Design Dossier that includes detailed information about the device, such as design, safety, and performance data. Next, you must undergo an assessment by a Notified Body, which will review your documentation and conduct an audit or testing if necessary. After successful evaluation, the Notified Body will issue a CE certificate. Do you need more details on any specific step or document?

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