Applying for EU CE certification of Class D medical devices involves a series of well-defined procedures to ensure compliance with the EU Medical Device Regulation (MDR) 2017/745. Here’s a step-by-step guide to the process:

1. Preliminary Preparation

• Understand MDR Requirements: Familiarize yourself with the MDR 2017/745, particularly the sections applicable to Class D devices (high-risk devices).
• Device Classification: Verify that your device is correctly classified as Class D based on its intended use and risk.

2. Develop Technical Documentation

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

3. Implement a Quality Management System (QMS)

• ISO 13485 Compliance: Develop and implement a QMS according to ISO 13485:2016. Ensure that the QMS includes:
  • Documented Procedures: Procedures for all quality management aspects.
  • Internal Audits: Regular internal audits to assess compliance and effectiveness.
  • Management Reviews: Periodic reviews of the QMS to address non-conformities and improve processes.

4. Choose and Engage a Notified Body

• Select a Notified Body: Identify and choose a Notified Body that is accredited for Class D medical devices. Check their scope of accreditation and reputation.
• Initial Communication: Contact the Notified Body to discuss the requirements and obtain application guidelines.

5. Submit Application to Notified Body

• Complete Application Form: Fill out the application form provided by the Notified Body.
• Submit Technical Documentation: Provide the Design Dossier and other required documentation.
• Pay Fees: Pay any fees associated with the application and certification process.

6. Notified Body Assessment

• Document Review: The Notified Body will review your submitted technical documentation for compliance with MDR requirements.
• On-Site Audit: An on-site audit will be conducted to assess your QMS and manufacturing processes. Ensure all documentation and procedures are available and in order.
• Address Findings: If the Notified Body identifies any issues or non-conformities, implement corrective actions and provide evidence of these actions.

7. Certification Decision

• Final Evaluation: After addressing any findings, the Notified Body will make a final decision on certification.
• Certification Issuance: If all requirements are met, the Notified Body will issue a CE certificate.
• CE Marking: Affix the CE mark to your device and ensure all labeling reflects the certification.

8. Post-Certification Responsibilities

• Post-Market Surveillance: Implement a post-market surveillance system to monitor the device’s performance and safety once it is on the market.
• Adverse Event Reporting: Report any serious adverse events or incidents to the relevant authorities and the Notified Body.
• Ongoing Compliance: Maintain compliance with MDR and ISO 13485. Update your technical documentation and QMS as needed.

9. Re-Certification and Continuous Improvement

• Re-Certification: Prepare for periodic re-certification audits by the Notified Body.
• Regulatory Updates: Stay updated on any changes in regulations or standards that may affect your device. Adapt your processes and documentation accordingly.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn