Obtaining Class B medical device CE certification typically takes between 6 to 12 months. The timeline can vary based on several factors:

1. Preparation Time: Gathering and preparing the required technical documentation and implementing a Quality Management System (QMS) can take several weeks to months, depending on the complexity of the device and your readiness.

2. Application Submission: Completing and submitting the application form to the Notified Body generally takes a few weeks.

3. Notified Body Review: The Notified Body's review of your documentation and QMS can take approximately 2 to 4 months. This includes any additional documentation requests or clarifications.

4. On-Site Audit: If an on-site audit is required, scheduling and conducting the audit can add additional time.

5. Certification Decision: The decision-making process and issuance of the CE certificate typically take 1 to 2 months after the review and audit.

6. Post-Certification: After receiving the CE certificate, you must affix the CE mark to your device and comply with ongoing regulatory requirements, which may also involve additional time for adjustments or improvements based on feedback.

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