To apply for EU CE certification for Class D medical devices, you should follow these steps:

1. Determine Device Classification

• Verify Classification: Confirm that your device is correctly classified as Class D under the EU Medical Device Regulation (MDR) 2017/745 based on its intended use and risk level.

2. Prepare Technical Documentation

• Create Design Dossier: Prepare a comprehensive Design Dossier that includes:
  • Device description and specifications.
  • Risk management documentation.
  • Clinical evaluation data.
  • Performance and safety testing results.
  • Manufacturing processes and quality controls.
  • Labeling and user instructions.

3. Implement Quality Management System (QMS)

• Establish ISO 13485 Compliance: Develop and implement a QMS compliant with ISO 13485 or an equivalent standard. Ensure all procedures are documented and followed.

4. Select a Notified Body

• Find a Notified Body: Choose a Notified Body accredited for Class D devices. You can find a list on the European Commission’s NANDO (New Approach Notified and Designated Organisations) database here.
• Contact: Reach out to the selected Notified Body to understand their requirements, application process, and fees.

5. Submit Application

• Complete Application Form: Fill out any required application forms provided by the Notified Body.
• Submit Technical Documentation: Provide the Notified Body with your Design Dossier, QMS documentation, and any other required materials.

6. Undergo Assessment

• Documentation Review: The Notified Body will review your Technical Documentation.
• Audits: They may perform an on-site audit of your manufacturing facilities and QMS.
• Respond to Feedback: Address any questions or issues raised by the Notified Body during their review.

7. Obtain CE Certificate

• Certification: If the Notified Body is satisfied with your submission, they will issue a CE certificate.
• Affix CE Mark: Once certified, you can affix the CE mark to your device and market it in the EU.

8. Post-Market Surveillance

• Implement System: Set up a system to monitor the device’s performance and safety in the market.
• Report Adverse Events: Report any adverse events or issues to the relevant authorities and the Notified Body.

Where to Handle It

• Notified Body: All interactions related to the certification process are handled through the selected Notified Body. They will guide you through the application process, conduct assessments, and issue the CE certificate.
• European Commission’s NANDO Database: Use this resource to find accredited Notified Bodies for your device.

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