The application process for Class B medical device CE certification involves several key steps to ensure that your device complies with the EU Medical Device Regulation (MDR) 2017/745. Here’s a detailed overview of the application process:

1. Preparation:

• Understand MDR Requirements: Review the EU Medical Device Regulation (MDR) 2017/745 and any relevant harmonized standards that apply to your Class B device.
• Compile Technical Documentation: Prepare comprehensive technical documentation, including:
  • Device description and intended use.
  • Design and manufacturing details.
  • Risk management (ISO 14971).
  • Clinical evaluation data.
  • Labeling and Instructions for Use (IFU).

2. Develop and Implement Quality Management System (QMS):

• ISO 13485 Compliance: Establish and implement a QMS that meets the ISO 13485 standards.
• Document Procedures: Ensure all processes are documented, including design control, production, and post-market surveillance.

3. Choose a Notified Body:

• Select an Accredited Notified Body: Choose a Notified Body that is authorized to assess Class B medical devices.
• Initial Contact: Reach out to the Notified Body to understand their application procedures, fees, and requirements.

4. Submit the Application:

• Complete Application Form: Fill out the application form provided by the Notified Body.
• Submit Technical Documentation: Provide the required technical documentation and evidence of your QMS to the Notified Body.

5. Notified Body Review:

• Documentation Review: The Notified Body reviews the submitted documentation to ensure compliance with MDR requirements.
• On-Site Audit: Prepare for and participate in an on-site audit where the Notified Body will assess your manufacturing processes and QMS.
• Address Queries: Respond to any additional questions or requests for further information from the Notified Body.

6. Certification Decision:

• Evaluation Outcome: The Notified Body will evaluate the documentation and audit results to make a certification decision.
• Issuance of CE Certificate: If the device meets all requirements, the Notified Body will issue a CE certificate.

7. Post-Certification Obligations:

• Affix CE Mark: Once certified, affix the CE mark to your device and its packaging.
• Implement Post-Market Surveillance: Establish a system to monitor the device’s performance and report any adverse events.
• Maintain Compliance: Continue to adhere to MDR requirements and keep your QMS up-to-date.

8. Renewal and Updates:

• Prepare for Renewals: Be aware of the certification’s validity period and prepare for renewal or recertification as needed.
• Inform of Changes: Notify the Notified Body of any significant changes to the device or its manufacturing processes.