To obtain CE certification for a Class B medical device in the EU, follow these procedures and steps:

1. Determine Classification: Confirm that your device falls under Class B based on its intended use and risk level.

2. Prepare Technical Documentation: Compile a technical file that includes device description, design and manufacturing information, risk assessment, clinical evaluations, and labeling.

3. Implement Quality Management System (QMS): Establish and document a QMS compliant with ISO 13485.

4. Choose a Notified Body: Select an accredited Notified Body that is designated to assess your type of device.

5. Submit Application: Provide your technical documentation and QMS information to the Notified Body.

6. Assessment by Notified Body: The Notified Body reviews your documentation, conducts audits if necessary, and may request additional information.

7. Receive CE Certificate: If your device meets the requirements, the Notified Body will issue a CE certificate.

8. Post-Market Surveillance: Implement and maintain a post-market surveillance system to monitor the device’s performance and report any issues.

9. Update Documentation: Keep your technical file and QMS up-to-date, including any changes to the device or regulations.