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

1. Classification and Regulatory Requirements

• Determine Device Classification: Confirm that your device is correctly classified as Class C according to the EU Medical Device Regulation (MDR) 2017/745.
• Understand MDR Requirements: Familiarize yourself with the specific requirements for Class C devices under the MDR.

2. Develop Technical Documentation

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

3. Implement Quality Management System (QMS)

• Adopt ISO 13485:2016: Implement a QMS that meets ISO 13485 requirements.
• Document Procedures: Develop and document all quality control and assurance procedures.

4. Select a Notified Body

• Choose a Notified Body: Select a Notified Body accredited to certify Class C medical devices.
• Understand Their Requirements: Familiarize yourself with the Notified Body’s specific requirements and processes.

5. Submit Application

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

6. Notified Body Evaluation

• Documentation Review: The Notified Body reviews your submitted documentation.
• On-Site Audit: An on-site audit may be conducted to verify compliance with MDR requirements and your QMS.
• Address Feedback: Respond to any feedback or corrective actions requested by the Notified Body.

7. Obtain Certification

• Certification Decision: If compliant, the Notified Body issues a CE certificate for your device.
• Declaration of Conformity: Prepare a Declaration of Conformity stating that your device meets all relevant requirements.

8. Post-Certification Requirements

• Post-Market Surveillance: Implement and maintain a post-market surveillance plan to monitor device 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.
• Monitor Regulatory Changes: Stay informed about updates to regulations and standards.