The process for obtaining EU CE certification for Class C medical devices involves several key steps, each crucial for compliance with the EU Medical Device Regulation (MDR) 2017/745. Here's an overview of the process:

1. Classification and Requirements

• Determine Classification: Confirm that your device is correctly classified as Class C based on its risk level and intended use.
• Understand MDR Requirements: Review the specific requirements for Class C devices under the MDR.

2. Technical Documentation Preparation

• Compile Technical Documentation: Prepare comprehensive documentation, including:
  • Device description and specifications.
  • Design and manufacturing information.
  • Risk management (ISO 14971).
  • Clinical evaluation (ISO 14155 and relevant guidelines).
  • Labeling and instructions for use.
• Conformity Assessment: Ensure your documentation demonstrates compliance with applicable standards and regulations.

3. Quality Management System (QMS)

• Implement ISO 13485:2016: Establish and maintain a Quality Management System compliant with ISO 13485.
• Document QMS Procedures: Create and document all quality control and assurance procedures.

4. Select a Notified Body

• Choose an Accredited Notified Body: Select a Notified Body that is accredited to certify Class C medical devices.
• Understand Their Process: Familiarize yourself with the Notified Body’s requirements and processes.

5. Submit Application

• Prepare and Submit Application: Submit your technical documentation and QMS details to the Notified Body.
• Pay Fees: Pay any required fees for the application and certification process.

6. Evaluation by Notified Body

• Document Review: The Notified Body reviews your technical documentation and QMS.
• On-Site Audit: An on-site audit may be conducted to assess compliance with MDR requirements and QMS.
• Feedback and Corrections: Address any issues or non-conformities identified during the evaluation.

7. Certification Decision

• Obtain CE Certificate: If the Notified Body is satisfied with your submission, they will issue a CE certificate for your Class C device.
• Conformity Declaration: Prepare a Declaration of Conformity stating that your device meets all relevant requirements.

8. Post-Market Activities

• Post-Market Surveillance: Implement and maintain a post-market surveillance plan to monitor the device’s performance and safety.
• Adverse Event Reporting: Report any serious incidents or adverse events to the Notified Body and relevant authorities.
• Periodic Updates: Keep documentation up-to-date and renew certification as required.

9. Continuous Compliance

• Maintain QMS: Ensure ongoing compliance with your QMS and regulatory requirements.
• Stay Informed: Monitor updates to regulations and standards, and adjust practices as necessary.

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