After obtaining CE certification for a Class B medical device, there are several important points to ensure ongoing compliance and successful market performance:

1. Post-Market Surveillance:

• Monitor Device Performance: Regularly collect and analyze data on the device's performance in the market.
• Report Adverse Events: Report any adverse events or incidents involving the device to the relevant authorities promptly.
• Update Risk Management: Continuously assess and update risk management procedures based on post-market feedback.

2. Documentation and Record-Keeping:

• Maintain Technical Documentation: Keep your technical documentation up-to-date and readily accessible for regulatory inspections or audits.
• Document Changes: Record any changes to the device, its manufacturing process, or its intended use, and assess their impact on safety and performance.

3. Quality Management System (QMS):

• Ensure Ongoing Compliance: Regularly review and update your QMS to maintain compliance with ISO 13485 and MDR requirements.
• Conduct Internal Audits: Perform periodic internal audits to verify that your QMS is effective and compliant.

4. Notified Body Communication:

• Inform About Changes: Notify the Notified Body of any significant changes to the device or its manufacturing process that may affect compliance.
• Renew Certification: Be aware of the certificate's expiration date and prepare for renewal if required.

5. Regulatory Updates:

• Stay Informed: Keep up-to-date with any changes to EU regulations, standards, or guidance that may affect your device.
• Implement Changes: Adapt your practices and documentation to comply with any new regulatory requirements.

6. Market and Customer Support:

• Provide Support: Ensure adequate customer support and training for users of the device to ensure proper usage.
• Address Feedback: Actively address any user feedback or complaints to improve the device's performance and safety.

7. Post-Market Clinical Follow-Up:

• Conduct Clinical Follow-Up: If applicable, conduct post-market clinical follow-up studies to gather further data on the device's performance and safety.

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