The time required to obtain EU CE certification for Class D medical devices can vary based on several factors, including the complexity of the device, the thoroughness of your documentation, and the Notified Body’s workload. Here’s a detailed overview of the typical timeline and audit processes:

Timeline for Obtaining EU CE Certification

1. Preparation Phase (1-3 Months)

   • Documentation Preparation: Time required to prepare and organize all necessary documentation, including the Design Dossier, clinical evaluations, risk management, and Quality Management System (QMS) documentation.
   • Quality Management System Implementation: Time to establish and implement a compliant QMS if not already in place.

2. Notified Body Selection and Application (1-2 Months)

   • Choosing a Notified Body: Researching and selecting a Notified Body accredited for Class D devices.
   • Application Submission: Completing and submitting the application along with the technical documentation.

3. Notified Body Assessment (3-6 Months)

   • Document Review: The Notified Body reviews the submitted technical documentation. This can take several weeks to months depending on the complexity and completeness of the submission.
   • On-Site Audit: An on-site audit may be conducted to assess compliance with the MDR and the effectiveness of your QMS. The scheduling of the audit may also affect the timeline.
   • Addressing Findings: If any issues or non-conformities are identified, corrective actions must be implemented and reviewed. This can add additional time to the certification process.

4. Certification Issuance (1-2 Months)

   • Final Review and Decision: Once all requirements are met and any corrective actions are addressed, the Notified Body will issue the CE certificate.
   • CE Marking: After receiving the certificate, you can affix the CE mark to your device and proceed with market access.

Total Estimated Time

• Overall Duration: The entire process typically takes between 6 to 12 months from the preparation phase to receiving the CE certificate. Complex devices or additional documentation requirements may extend this timeline.

Audit Processes

1. Document Review

   • Initial Review: The Notified Body conducts an initial review of the submitted technical documentation to ensure it meets the MDR requirements.
   • Detailed Analysis: The review includes an assessment of the Design Dossier, risk management, clinical evaluations, and other critical documentation.

2. On-Site Audit

   • Audit Planning: The Notified Body schedules and plans the on-site audit, which includes assessing your Quality Management System (QMS) and manufacturing processes.
   • Audit Execution: Auditors review processes, procedures, and records to ensure compliance with MDR and ISO 13485. They may interview staff, inspect facilities, and review records.
   • Audit Report: After the audit, the Notified Body provides a report detailing any findings or non-conformities. You will need to address these issues and provide evidence of corrective actions.

3. Post-Audit Follow-Up

   • Corrective Actions: Implement corrective actions to address any findings from the audit. The Notified Body may require additional documentation or follow-up audits to verify that issues have been resolved.
   • Final Evaluation: The Notified Body conducts a final evaluation of the corrective actions and makes a decision regarding certification.

4. Certification Issuance

   • Certificate Issuance: Once all requirements are satisfied, and the Notified Body is satisfied with the corrective actions, they issue the CE certificate.
   • Market Access: You can then affix the CE mark to your device and begin distributing it in the EU market.

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