Before applying for EU CE certification for Class C medical devices, thorough preparatory work is essential to ensure a smooth and successful certification process. Here are key steps to take:

1. Understand the Requirements

• Familiarize Yourself with the EU MDR: Review the EU Medical Device Regulation (MDR) 2017/745 to understand the specific requirements for Class C devices.

2. Classification and Documentation

• Verify Classification: Ensure your device is correctly classified as Class C based on its intended use and risk profile.
• Compile Technical Documentation: Prepare comprehensive technical documentation, including device description, design and manufacturing information, risk management, clinical evaluation, labeling, and instructions for use.

3. Quality Management System (QMS)

• Implement ISO 13485: Establish a Quality Management System compliant with ISO 13485:2016 to manage all aspects of device production and ensure regulatory compliance.
• Document QMS Procedures: Document all procedures and processes related to quality control and assurance.

4. Clinical Evaluation

• Conduct Clinical Trials: If applicable, perform clinical trials or gather clinical evidence to support the safety and effectiveness of your device.
• Prepare Clinical Evaluation Report (CER): Compile a CER based on clinical data and literature.

5. Risk Management

• Perform Risk Analysis: Identify and assess potential risks associated with the device and implement risk control measures.
• Prepare Risk Management Report: Document the risk management process and outcomes.

6. Select a Notified Body

• Choose an Appropriate Notified Body: Select a Notified Body accredited to certify Class C medical devices. Verify their expertise in your device type.
• Understand Their Process: Familiarize yourself with the Notified Body's application and assessment process.

7. Prepare for Audit and Inspection

• Organize Documentation: Ensure all required documents are organized and readily accessible for the Notified Body’s review.
• Prepare for On-Site Audit: Be ready for potential on-site audits of your manufacturing facility and QMS.

8. Post-Market Surveillance Plan

• Develop a Surveillance Plan: Create a plan for monitoring the device’s performance and safety post-market, including procedures for adverse event reporting and corrective actions.

9. Training and Awareness

• Train Your Team: Ensure that your team is trained on the EU MDR requirements, the QMS, and the documentation process.

10. Review and Update

• Regulatory Updates: Stay informed about any updates to EU regulations and standards that may impact your certification process.

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