The process for obtaining EU CE certification for Class C medical devices involves several detailed steps. Here’s a comprehensive overview:

1. Understand Classification

• Confirm that your device is classified as Class C according to the EU MDR (Medical Device Regulation) 2017/745. Class C devices are high-risk and require extensive evaluation.

2. Develop Technical Documentation

• Device Description: Provide detailed descriptions of the device, including its intended use and operating principles.
• Design and Manufacturing Information: Include information on the design, manufacturing process, and quality control measures.
• Risk Management: Document the risk analysis and mitigation strategies.
• Labeling and Instructions for Use: Ensure that labeling and user instructions comply with regulatory requirements.
• Clinical Evaluation: Present data from clinical trials or literature demonstrating the safety and performance of the device.

3. Conduct Clinical Evaluation

• Perform clinical trials if necessary to gather evidence on safety and effectiveness. The clinical evaluation must be based on scientific literature or clinical experience.

4. Choose a Notified Body

• Select a Notified Body that is designated for Class C devices. The Notified Body will be responsible for assessing your documentation and evaluating compliance with the EU MDR.

5. Prepare and Submit Application

• Submit your application, including all technical documentation and clinical evaluation reports, to the chosen Notified Body.

6. Notified Body Evaluation

• The Notified Body will review your submission. They may request additional information or changes. This process includes:
  • Document Review: Checking the completeness and accuracy of the technical file.
  • On-Site Audit: Inspecting the manufacturing facilities and quality management systems.

7. Address Findings

• Address any issues or non-compliances identified by the Notified Body. You may need to revise your documentation or make improvements to your device or processes.

8. Receive CE Certificate

• Once the Notified Body is satisfied with your submission, they will issue a CE certificate. This certificate allows you to legally market your device in the EU.

9. Post-Market Surveillance

• Implement a post-market surveillance system to monitor the device's performance and address any issues that arise after it is on the market.

10. Maintain Compliance

• Continuously comply with EU regulations, including updates to the MDR, and ensure ongoing conformity through regular reviews and audits.