Obtaining EU CE certification for Class D medical devices involves a structured process that ensures your device meets the stringent requirements set forth by the EU Medical Device Regulation (MDR) 2017/745. Here’s a detailed overview of the process and steps involved:

1. Understand the MDR Requirements

• Regulation Familiarization: Thoroughly review the EU Medical Device Regulation (MDR) 2017/745 to understand the requirements for Class D devices.
• Classification Confirmation: Ensure that your device is correctly classified as Class D based on its intended use and risk level.

2. Prepare Technical Documentation

• Design Dossier: Compile a comprehensive Design Dossier that includes:
  • Device Description: Detailed description of the device, including its intended use and design.
  • Risk Management: Documentation of the risk management process according to ISO 14971.
  • Clinical Evaluation: Clinical data demonstrating the safety and performance of the device, including a Clinical Evaluation Report.
  • Performance Testing: Results of performance and safety testing.
  • Labeling and Instructions for Use (IFU): Drafts of the labeling and IFU in compliance with MDR requirements.
  • Manufacturing Information: Details about the manufacturing process, including quality control measures.

3. Implement a Quality Management System (QMS)

• ISO 13485 Compliance: Develop and implement a QMS in accordance with ISO 13485:2016. This includes:
  • Documented Procedures: Create and maintain documented procedures for quality management.
  • Internal Audits: Conduct regular internal audits to assess QMS effectiveness.
  • Management Review: Perform periodic management reviews to ensure QMS compliance.

4. Select and Engage a Notified Body

• Choose a Notified Body: Select a Notified Body accredited to assess Class D medical devices. Research their requirements and processes.
• Initial Contact: Reach out to the Notified Body to discuss your device, application requirements, and fees.

5. Submit the Application

• Application Submission: Submit your application to the Notified Body, including the complete Design Dossier and other required documentation.
• Fees and Contracts: Pay any applicable fees and enter into a contract with the Notified Body for certification services.

6. Notified Body Assessment

• Document Review: The Notified Body will review your technical documentation to ensure it meets MDR requirements.
• On-Site Audit: An on-site audit may be conducted to assess your QMS and manufacturing processes.
• Corrective Actions: Address any findings or non-conformities identified during the assessment.

7. Certification Decision

• Approval: If your application meets all requirements, the Notified Body will issue a CE certificate.
• Certification Issuance: Receive the CE certificate, which allows you to affix the CE mark to your device.

8. Post-Market Obligations

• Post-Market Surveillance: Implement a system for ongoing monitoring of the device’s performance and safety in the market.
• Adverse Event Reporting: Report any serious adverse events or device defects to the relevant authorities and the Notified Body.
• Technical Documentation Updates: Keep your technical documentation up-to-date and revise it as needed.

9. Maintain Compliance

• Re-certification: Prepare for periodic re-certification audits by the Notified Body.
• Regulatory Changes: Stay informed about any changes in EU regulations and standards that may affect your device.

10. Market Access

• Distribution: Ensure that your device is properly labeled with the CE mark and that all required documentation accompanies it for distribution in the EU.

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