The time required to obtain EU CE certification for Class C medical devices can vary based on several factors, including the complexity of the device, the completeness of the application, and the Notified Body's workload. Typically, the process can take 6 to 12 months. Here’s a breakdown of the stages:

1. Preparation of Documentation (2-3 months): Gathering and preparing technical documentation, including clinical evaluations and risk management reports.

2. Notified Body Review (2-4 months): The Notified Body reviews the submitted documentation. This includes an initial review and possibly requests for additional information.

3. On-Site Audit (1-2 months): Scheduling and conducting an on-site audit, if required, to assess compliance with the MDR and the QMS.

4. Certification Decision (1-2 months): Final assessment by the Notified Body and issuance of the CE certificate if all requirements are met.

Key Factors Influencing Timing:

• Device Complexity: More complex devices may require additional time for review and audits.
• Completeness of Submission: Well-prepared and complete documentation can expedite the process.
• Notified Body’s Workload: The time frame can be influenced by the Notified Body’s current workload and availability.

It's essential to plan for potential delays and maintain open communication with your Notified Body throughout the process.

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