To apply for EU CE certification for Class C medical devices, follow these steps:
Determine Device Classification: Confirm that your device is correctly classified as Class C based on the risk it poses.
Prepare Technical Documentation: Compile a comprehensive technical file, including product specifications, design and manufacturing processes, and risk management documentation.
Conduct Clinical Evaluation: Provide evidence of clinical safety and efficacy through clinical trials or literature.
Choose a Notified Body: Select a Notified Body accredited to assess Class C devices.
Submit Documentation: Submit your technical documentation and clinical data to the Notified Body.
Undergo Evaluation: The Notified Body will review your submission and may request additional information or modifications.
Receive Certification: Upon successful evaluation, the Notified Body will issue a CE certificate, allowing you to market your device in the EU.
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