To obtain EU CE certification for Class C medical devices, you must meet several specific requirements:

1. Regulatory Framework

• EU MDR 2017/745: Ensure compliance with the Medical Device Regulation (MDR), which governs the certification process for medical devices in the EU.

2. Technical Documentation

• Device Description: Include detailed information about the device, including its design, intended use, and operational principles.
• Design and Manufacturing Information: Provide documentation on the design process, manufacturing procedures, and quality control measures.
• Risk Management: Document the risk management process, including risk analysis and mitigation strategies.
• Labeling and Instructions for Use: Ensure that labeling and instructions comply with EU regulations, providing clear information on safe use.
• Clinical Evaluation: Provide evidence of clinical safety and performance through clinical trials or scientific literature.

3. Clinical Evaluation

• Clinical Trials: Conduct clinical trials if necessary to demonstrate the device’s safety and effectiveness.
• Clinical Evidence: Gather and present clinical evidence through studies, literature, or clinical experience.

4. Quality Management System (QMS)

• Implement a Quality Management System (QMS) in accordance with ISO 13485. This system should cover all aspects of the device’s lifecycle, including design, production, and post-market activities.

5. Notified Body Selection

• Designation: Choose a Notified Body designated for Class C devices. Ensure that the Notified Body is accredited to assess your specific type of device.
• Application Submission: Submit your technical documentation and clinical data to the Notified Body for evaluation.

6. Notified Body Evaluation

• Document Review: The Notified Body will review your technical file and clinical evaluation reports.
• On-Site Audits: The Notified Body may conduct on-site inspections of your manufacturing facilities and QMS.

7. Address Non-Conformities

• Respond to any issues or non-compliances identified by the Notified Body. This may involve revising documentation, improving processes, or conducting additional testing.

8. CE Marking

• Upon successful evaluation, the Notified Body will issue a CE certificate. You can then affix the CE mark to your device, signifying compliance with EU regulations.

9. Post-Market Surveillance

• Monitoring: Implement a post-market surveillance system to monitor the device’s performance and safety once it is on the market.
• Reporting: Report any adverse events or safety issues to the relevant authorities and take corrective actions as necessary.

10. Ongoing Compliance

• Regulatory Updates: Stay informed about updates to the MDR and ensure ongoing compliance with any new requirements or changes in legislation.

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