The processing time for EU CE certification of Class C medical devices typically involves several phases and can vary based on various factors. Here’s a general outline:

1. Preparation Time

• Technical Documentation: Preparing the necessary documentation, including the technical file, clinical evaluation, and risk management, can take several months to a year depending on the complexity of the device and the completeness of the data.

2. Application Submission

• Submission: Once all documentation is ready, the actual submission to the Notified Body usually takes a few weeks.

3. Notified Body Evaluation

• Document Review: The review of submitted documents by the Notified Body typically takes 3 to 6 months. This period may vary depending on the Notified Body’s workload and the complexity of the device.
• On-Site Audit: If required, on-site audits of manufacturing facilities and quality management systems can add additional time, usually several weeks to a few months, depending on scheduling and findings.

4. Addressing Feedback

• Corrections and Revisions: If the Notified Body identifies issues or requires additional information, addressing these concerns can extend the processing time. This phase may add several weeks to a few months.

5. Issuance of Certificate

• Final Approval: After the review and any necessary revisions, the Notified Body will issue the CE certificate, which may take a few additional weeks.

Overall Timeframe

• Total Duration: From start to finish, the process generally takes about 6 to 12 months. However, more complex devices or additional regulatory requirements can lengthen this timeframe.