To obtain EU CE certification for Class C medical devices, follow this detailed process:

Process:

1. Device Classification

   • Verify that your device is correctly classified as Class C under the EU MDR 2017/745 based on its intended use and risk.

2. Prepare Technical Documentation

   • Device Description: Detailed information about the device, including design and intended use.
   • Design and Manufacturing Information: Documentation of the design process, manufacturing procedures, and quality controls.
   • Risk Management: Comprehensive risk assessment and mitigation strategies.
   • Clinical Evaluation: Data from clinical trials or literature demonstrating safety and performance.
   • Labeling and Instructions for Use: Compliance with EU requirements for labeling and instructions.

3. Clinical Evaluation

   • Conduct clinical trials if needed to provide evidence of safety and efficacy.
   • Prepare a Clinical Evaluation Report (CER) based on clinical data.

4. Implement Quality Management System (QMS)

   • Ensure compliance with ISO 13485 for a QMS that covers all aspects of the device's lifecycle.

5. Select and Apply to a Notified Body

   • Find a Notified Body: Choose one accredited for Class C devices from the NANDO database.
   • Submit Application: Provide the Notified Body with your technical documentation, clinical data, and QMS information.

6. Undergo Evaluation

   • Document Review: The Notified Body reviews your submission.
   • On-Site Audit: The Notified Body may conduct an audit of your manufacturing facilities and QMS.

7. Address Findings

   • Respond to any issues or non-compliances identified by the Notified Body. Make necessary revisions.

8. Receive CE Certification

   • Upon successful evaluation, the Notified Body issues a CE certificate, allowing you to affix the CE mark to your device.

9. Post-Market Surveillance

   • Implement a post-market surveillance plan to monitor device performance and address any issues that arise.

10. Ongoing Compliance

    • Stay updated with changes in EU regulations and ensure ongoing compliance with the MDR.

Required Materials:

• Technical File or Design Dossier
• Clinical Evaluation Report (CER)
• Risk Management File
• Quality Management System (QMS) documentation
• Labeling and Instructions for Use

Considerations:

• Device Complexity: More complex devices may require more extensive documentation and clinical data.
• Notified Body Selection: Choose a Notified Body with expertise in your specific type of device.
• Regulatory Changes: Stay informed about updates to EU regulations that may affect your certification.