The application process for EU CE certification for Class C medical devices involves several detailed steps, ensuring that your device meets the requirements set forth by the EU Medical Device Regulation (MDR) 2017/745. Here’s a comprehensive outline of the application process:

1. Preliminary Steps

Device Classification

• Confirm Classification: Verify that your device is correctly classified as Class C according to the MDR.
• Understand Requirements: Familiarize yourself with the specific regulatory requirements and standards applicable to Class C devices.

Prepare Technical Documentation

• Compile Documentation: Gather all necessary documents, including:
  • Device description and intended use.
  • Design and manufacturing details.
  • Risk management (ISO 14971).
  • Clinical evaluation (ISO 14155 and relevant guidelines).
  • Labeling and Instructions for Use (IFU).
• Compliance Check: Ensure documentation meets MDR requirements and relevant standards.

2. Quality Management System (QMS)

Implement QMS

• ISO 13485:2016: Develop and maintain a Quality Management System compliant with ISO 13485.
• Document Procedures: Document all quality control, assurance procedures, and processes.

3. Select a Notified Body

Choose an Accredited Notified Body

• Find a Notified Body: Select a Notified Body that is authorized to certify Class C medical devices.
• Understand Requirements: Review the Notified Body’s specific requirements and procedures for certification.

4. Application Submission

Prepare Application Package

• Compile Application: Prepare and submit an application package to the Notified Body, including:
  • Technical documentation.
  • QMS documentation.
  • Any additional required information.
• Fee Payment: Pay the application and certification fees.

5. Evaluation by Notified Body

Document Review

• Initial Review: The Notified Body reviews the submitted technical documentation and QMS.
• Request for Information: Respond to any requests for additional information or clarification.

On-Site Audit

• Audit Scheduling: Schedule an on-site audit if required.
• Conduct Audit: The Notified Body conducts an on-site audit to assess compliance with MDR requirements and your QMS.
• Corrective Actions: Address any issues or non-conformities identified during the audit.

6. Certification Decision

Evaluation and Issuance

• Final Assessment: The Notified Body evaluates all findings and documentation.
• Certification Issuance: If the device is found to be compliant, the Notified Body issues a CE certificate.
• Declaration of Conformity: Prepare and maintain a Declaration of Conformity, stating that your device meets all relevant EU requirements.

7. Post-Certification Requirements

Post-Market Surveillance

• Implement Plan: Develop and maintain a post-market surveillance plan to monitor device performance and safety.
• Adverse Event Reporting: Report any serious incidents or adverse events to the Notified Body and relevant authorities.

Periodic Updates

• Renew Certification: Prepare for periodic renewal of your CE certification.
• Regulatory Updates: Stay informed about updates to regulations and standards, and adjust your practices as needed.

Summary of Application Process

1. Preliminary Steps: Confirm device classification and prepare technical documentation.
2. QMS: Implement and document ISO 13485-compliant quality management system.
3. Notified Body Selection: Choose an accredited Notified Body and understand their requirements.
4. Application Submission: Prepare and submit the application package, including technical and QMS documentation.
5. Evaluation: Undergo documentation review and on-site audit by the Notified Body.
6. Certification Decision: Receive CE certificate and prepare the Declaration of Conformity.
7. Post-Certification: Implement post-market surveillance and adhere to periodic update requirements.

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