To obtain EU CE certification for Class I medical devices, manufacturers must comply with several key requirements outlined in the EU Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Device Regulation (IVDR) 2017/746, depending on the type of device. Here are the primary requirements:

1. Device Classification

• Confirm Classification: Ensure that the device is correctly classified as Class I under the MDR or IVDR. Class I devices are generally low-risk and include products like bandages or simple surgical instruments.

2. Technical Documentation

• Device Description: Provide a detailed description of the device, including its intended use and how it operates.
• Design and Manufacturing Information: Document the design and manufacturing processes, including specifications and drawings.
• Risk Management: Conduct 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 may be required. This should follow guidelines set out in the relevant regulations.
• Instructions for Use: Create clear and comprehensive user manuals, labeling, and instructions for the device.
• Quality Management System (QMS): While Class I devices do not typically require full ISO 13485 certification, manufacturers must have documented procedures in place that align with QMS principles.

3. Declaration of Conformity

• Prepare Declaration: Draft a Declaration of Conformity that states the device complies with all relevant EU regulations. This document must include:
  • Device details (name, model).
  • Manufacturer’s name and address.
  • Compliance with EU regulations and standards.
  • References to the relevant harmonized standards used.
  • The date of issue and the signature of the authorized person.

4. CE Marking

• Affix CE Mark: After preparing the technical documentation and the Declaration of Conformity, affix the CE mark to the device. The CE mark should be placed on the device, its packaging, or the accompanying documentation.

5. Post-Market Surveillance

• Monitor Device Performance: Implement a post-market surveillance system to monitor the device’s performance and handle any adverse events. This includes:
  • Tracking and investigating complaints.
  • Regularly reviewing device performance and safety.
  • Maintaining records of post-market surveillance activities.

6. Labeling and Instructions for Use

• Compliance: Ensure that all labels and instructions for use comply with EU requirements. This includes:
  • The CE mark.
  • Manufacturer’s details.
  • Instructions for proper use and any warnings or precautions.
  • Any other required information specific to the device type and its use.

7. Authorized Representative

• For Non-EU Manufacturers: If the manufacturer is not based in the EU, they must appoint an Authorized Representative located within the EU who will act on their behalf and handle regulatory matters.

8. Registration (if required)

• National Authorities: Some EU member states may have additional registration requirements for Class I devices. Verify if registration with national competent authorities is required in the countries where the device will be marketed.

Key Standards and Guidelines

• Harmonized Standards: Ensure compliance with relevant harmonized standards, such as ISO 13485 for quality management, ISO 14971 for risk management, and other applicable standards.

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