How to apply for EU CE certification for Class C medical devices?
Release time:2024-08-16 10:55:02 The author: source:
Determine Device Classification: Confirm that your device is correctly classified as Class C based on the risk it poses.

To apply for EU CE certification for Class C medical devices, follow these steps:

  1. Determine Device Classification: Confirm that your device is correctly classified as Class C based on the risk it poses.

  2. Prepare Technical Documentation: Compile a comprehensive technical file, including product specifications, design and manufacturing processes, and risk management documentation.

  3. Conduct Clinical Evaluation: Provide evidence of clinical safety and efficacy through clinical trials or literature.

  4. Choose a Notified Body: Select a Notified Body accredited to assess Class C devices.

  5. Submit Documentation: Submit your technical documentation and clinical data to the Notified Body.

  6. Undergo Evaluation: The Notified Body will review your submission and may request additional information or modifications.

  7. 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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