Obtaining EU CE certification for Class I medical devices involves several key steps. Here's a detailed outline of the process:

1. Determine Classification

• Verify Classification: Confirm that your device is indeed classified as Class I under the EU Medical Device Regulation (MDR) 2017/745 or In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Class I devices are typically low-risk and may include items like bandages, simple surgical instruments, or certain diagnostic tools.

2. Develop Technical Documentation

• Device Description: Provide a comprehensive description of the device, its intended purpose, and how it works.
• Design and Manufacturing Information: Include detailed drawings, specifications, and descriptions of the design and manufacturing processes.
• Risk Management: Perform a risk assessment following ISO 14971 to identify and mitigate potential risks associated with the device.
• Clinical Evaluation: For some Class I devices, clinical evidence or a literature review demonstrating safety and performance is required.
• Instructions for Use: Develop user manuals, labeling, and instructions according to regulatory requirements.
• Quality Management System (QMS): Implement a QMS according to ISO 13485. While Class I devices typically do not require full certification, you should still have documented processes and procedures in place.

3. Prepare the Declaration of Conformity

• Draft the Declaration: Prepare a Declaration of Conformity stating that your device meets all relevant EU requirements. This document should include:
  • Device information.
  • Manufacturer details.
  • Compliance with relevant EU regulations.
  • Details of the device's conformity with applicable standards.

4. Affix the CE Marking

• Mark the Device: Once the technical documentation is complete and the Declaration of Conformity is prepared, affix the CE mark to the device. Ensure the CE mark is visible on the device and its packaging, along with any required labeling information.

5. Register the Device (if applicable)

• National Competent Authorities: Some EU member states may require registration of the device with the national competent authority before placing it on the market. Check the specific requirements of the countries where you plan to sell the device.

6. Implement Post-Market Surveillance

• Monitor Performance: Establish and maintain a system for monitoring the device’s performance once it’s on the market. This includes handling adverse events and conducting regular reviews.
• Complaint Handling: Develop a procedure for managing and investigating complaints related to the device.

7. Maintain Documentation

• Documentation Management: Keep all technical documentation, the Declaration of Conformity, and records of post-market surveillance available for inspection by competent authorities. These documents should be maintained for the duration of the device's lifecycle and potentially beyond, depending on regulatory requirements.

Additional Considerations

• Authorized Representative: If your company is not based in the EU, you must appoint an Authorized Representative located within the EU who will act on your behalf.
• Labeling Requirements: Ensure that all labels and instructions for use comply with EU regulations and include the CE mark and any other required information.

Resources

• EU MDR and IVDR: Refer to the specific regulations for detailed requirements.
• Regulatory Consultants: Consider consulting with experts or regulatory bodies for guidance tailored to your specific device.