To apply for Class B medical device CE certification in the EU, you must meet the following conditions:

1. Compliance with Medical Device Regulation (MDR):

• Regulation: Ensure compliance with the EU Medical Device Regulation (2017/745). This includes adhering to the general safety and performance requirements outlined in the regulation.

2. Technical Documentation:

• Device Description: Provide detailed information about the device, including its intended use and functionality.
• Design and Manufacturing Information: Include specifications, design drawings, and details of the manufacturing process.
• Risk Management: Conduct a risk analysis and provide a risk management report.
• Clinical Evaluation: Submit clinical data or literature supporting the device's safety and performance.
• Labeling: Include instructions for use, labeling, and packaging details.
• User Manuals: Provide comprehensive guides for the end-user, including safety warnings and operational instructions.

3. Quality Management System (QMS):

• ISO 13485 Compliance: Implement and document a QMS that complies with ISO 13485 standards.
• QMS Procedures: Ensure procedures are in place for design control, manufacturing, and post-market surveillance.

4. Notified Body Involvement:

• Select Notified Body: Choose an accredited Notified Body that is authorized to assess your type of device.
• Submit Application: Provide the Notified Body with your technical documentation and QMS information for review.

5. Risk Classification:

• Correct Classification: Verify that your device is correctly classified as Class B. Class B devices are typically medium-risk devices that may include diagnostic equipment or non-invasive devices.

6. Post-Market Surveillance:

• System Implementation: Establish and maintain a post-market surveillance system to monitor the device’s performance and report any issues or adverse events.

7. Application Forms and Fees:

• Complete Forms: Fill out the application forms required by the Notified Body.
• Pay Fees: Be prepared to cover the costs associated with the certification process, including Notified Body fees and any additional costs for documentation preparation.

8. Documentation Accuracy:

• Ensure Accuracy: All documentation must be accurate, complete, and up-to-date to facilitate a smooth review process by the Notified Body.

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