Obtaining EU CE certification for Class C medical devices can be a time-consuming process. The duration typically ranges from several months to over a year, depending on various factors such as the complexity of the device, the efficiency of your preparation, and the responsiveness of the Notified Body. Here’s a breakdown of the review process stages:

1. Preparation Phase (1-3 months)

• Technical Documentation: Compile all necessary documentation, including device specifications, risk management, clinical evaluations, and labeling.
• Quality Management System (QMS): Implement and document an ISO 13485-compliant QMS.
• Pre-Submission Review: Optionally, conduct an internal or pre-submission review to ensure completeness and accuracy.

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

• Select Notified Body: Choose a Notified Body accredited for Class C devices.
• Submit Application: Prepare and submit the application to the Notified Body along with required documentation and fees.

3. Documentation Review (2-4 months)

• Initial Review: The Notified Body reviews your submitted technical documentation and QMS.
• Additional Information: If needed, the Notified Body may request additional information or clarifications, which could extend the review period.

4. On-Site Audit (1-2 months)

• Audit Scheduling: Schedule and prepare for the on-site audit by the Notified Body.
• Conduct Audit: The Notified Body conducts an on-site audit to assess compliance with MDR and your QMS.
• Corrective Actions: Address any issues or non-conformities identified during the audit.

5. Certification Decision (1-2 months)

• Evaluation of Findings: The Notified Body evaluates audit findings and documentation.
• Issuance of Certificate: If compliant, the Notified Body issues a CE certificate. If not, further corrective actions may be required.

6. Post-Certification Activities

• Conformity Declaration: Prepare and maintain the Declaration of Conformity.
• Post-Market Surveillance: Implement post-market surveillance and vigilance systems as required.

Summary Timeline

• Total Duration: Approximately 6 to 12 months, depending on the complexity of the device, the efficiency of documentation preparation, and the Notified Body’s processing times.