Before applying for Class B medical device CE certification, you should complete the following preparatory work:

1. Understand Regulatory Requirements:

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

2. Develop Technical Documentation:

• Compile Essential Documents: Prepare a detailed technical file including device descriptions, design and manufacturing details, risk management documentation, clinical evaluations, and labeling.
• Ensure Compliance: Ensure that the documentation meets all MDR requirements and is complete and accurate.

3. Implement a Quality Management System (QMS):

• ISO 13485 Compliance: Develop and implement a QMS compliant with ISO 13485, covering design, production, and post-market activities.
• Establish Procedures: Document procedures for quality control, risk management, and post-market surveillance.

4. Conduct Risk Management:

• Perform Risk Assessment: Identify potential risks associated with the device and implement measures to mitigate them.
• Prepare Risk Management File: Document the risk analysis and risk control measures in your technical file.

5. Prepare Clinical Evaluation:

• Gather Clinical Data: Collect clinical data or literature to demonstrate the device’s safety and performance.
• Compile Clinical Evaluation Report: Prepare a comprehensive report summarizing the clinical evidence.

6. Select a Notified Body:

• Choose an Accredited Notified Body: Identify and select a Notified Body authorized to assess Class B medical devices.
• Understand Their Requirements: Familiarize yourself with the Notified Body’s specific application procedures and requirements.

7. Develop Labeling and Instructions for Use (IFU):

• Create Clear Labels: Develop device labels with necessary information, including manufacturer details and usage instructions.
• Prepare User Manuals: Ensure that instructions for use are clear, comprehensive, and compliant with MDR requirements.

8. Review and Finalize Documentation:

• Internal Review: Conduct an internal review of all documentation and QMS procedures to ensure accuracy and completeness.
• Seek Expert Advice: Consider consulting with regulatory experts or consultants to verify that your application is in order.