The time to obtain EU CE certification for Class C medical devices typically ranges from 6 to 12 months. Here’s a general breakdown of the process:

1. Preparation of Documentation (2-3 months): Assembling technical documentation, clinical evaluations, risk management reports, and ensuring your Quality Management System (QMS) is in place.

2. Application and Initial Review (1-2 months): Submitting the application to the Notified Body and initial review of documents.

3. On-Site Audit (1-2 months): If required, scheduling and conducting an on-site audit by the Notified Body to evaluate compliance with the MDR and QMS.

4. Certification Decision (1-2 months): The Notified Body reviews all information, resolves any issues, and makes a certification decision.

Factors Affecting Duration:

• Device Complexity: More complex devices may require additional time for review and audit.
• Completeness of Submission: Thorough and complete documentation can expedite the process.
• Notified Body’s Schedule: The Notified Body’s workload and scheduling availability can influence the timeline.

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