To obtain EU CE certification for Class D medical devices, you must meet several stringent requirements under the European Union Medical Device Regulation (MDR) 2017/745. Here’s a detailed overview of the requirements:

1. Compliance with MDR 2017/745

• Regulatory Framework: Ensure that your device complies with the MDR, which outlines the essential requirements for medical devices in the EU.

2. Technical Documentation (Design Dossier)

• Device Description: Provide a detailed description of the device, including its intended use, design, and operational principles.
• Risk Management: Implement a comprehensive risk management process (e.g., ISO 14971) and provide documentation on identified risks and their mitigation.
• Clinical Evaluation: Present robust clinical data demonstrating the device’s safety and performance. This may include clinical trials, studies, and literature reviews.
• Performance and Safety Testing: Include results from testing to verify the device’s performance and safety.
• Manufacturing Information: Detail manufacturing processes, quality control measures, and facilities.
• Labeling and Instructions for Use: Ensure clear and comprehensive labeling and user instructions compliant with MDR requirements.

3. Quality Management System (QMS)

• ISO 13485 Compliance: Implement and maintain a QMS that meets the requirements of ISO 13485 or an equivalent standard.
• Documentation: Provide detailed documentation of your QMS procedures, including quality control, production processes, and post-market surveillance.

4. Clinical Evidence

• Clinical Trials: For Class D devices, clinical evidence is crucial. Conduct clinical trials if necessary and provide evidence that the device performs as intended.
• Post-Market Clinical Follow-up (PMCF): Develop a PMCF plan to gather additional clinical data after the device is on the market.

5. Notified Body Involvement

• Selection: Choose a Notified Body accredited for Class D devices.
• Application: Submit your Technical Documentation (Design Dossier) to the Notified Body along with your application for CE certification.
• Assessment: The Notified Body will review your documentation and may perform an on-site audit of your facilities and QMS.

6. Risk Management and Mitigation

• Risk Analysis: Conduct a thorough risk analysis and document how risks are managed throughout the device lifecycle.
• Mitigation Strategies: Provide evidence of effective risk mitigation measures.

7. Post-Market Surveillance

• Monitoring: Implement a post-market surveillance system to monitor the device’s performance in the market and gather feedback.
• Reporting: Report any adverse events and implement corrective actions as needed.

8. Regulatory Updates and Compliance

• Ongoing Compliance: Keep your documentation, QMS, and clinical evaluations up to date. Be prepared for periodic reviews and audits by the Notified Body.
• Changes: Report significant changes to the device or its use to the Notified Body.

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