For EU CE certification of Class D medical devices, the applicable standards are essential to ensure that your device meets the requirements set by the EU Medical Device Regulation (MDR) 2017/745. Class D devices are high-risk, so they must comply with rigorous standards. Here’s an overview of the key standards and regulations you should consider:

1. EU Medical Device Regulation (MDR) 2017/745

• Regulation Details: The MDR 2017/745 provides the overarching legal framework for medical devices in the EU. Compliance with this regulation is mandatory for obtaining CE certification.
• Key Sections: Ensure you adhere to the requirements for:
  • Clinical Evaluation (Article 61)
  • Risk Management (Article 10)
  • Quality Management System (Article 10)
  • Post-Market Surveillance (Article 83)

2. Harmonized Standards

Harmonized standards are voluntary standards developed by recognized standardization bodies that provide detailed technical specifications to meet MDR requirements. For Class D devices, you should consult the following:

• ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes

  • Purpose: Specifies requirements for a quality management system to ensure the consistent design, development, production, and delivery of medical devices.

• ISO 14971:2019 - Medical devices — Application of risk management to medical devices

  • Purpose: Provides a framework for managing risks associated with medical devices.

• ISO 10993 Series - Biological evaluation of medical devices

  • Purpose: Covers biocompatibility testing of medical devices, including cytotoxicity, sensitization, and other biological responses.

• IEC 60601 Series - Medical electrical equipment

  • Purpose: Specifies general safety and performance requirements for medical electrical equipment. Notable standards within this series include:
    • IEC 60601-1: General requirements for basic safety and essential performance.
    • IEC 60601-1-2: Electromagnetic compatibility requirements.
    • IEC 60601-1-6: Usability requirements.

• ISO 14155:2020 - Clinical investigations of medical devices for human subjects — Good clinical practice

  • Purpose: Provides guidelines for conducting clinical trials on medical devices.

3. Specific Device Standards

Depending on the type of Class D medical device, additional specific standards may apply. For example:

• ISO 13485:2016 - Applies to a wide range of medical devices, ensuring compliance with quality management systems.
• ISO 14971:2019 - Essential for risk management in high-risk devices.

4. European Standards (EN)

Some European standards are harmonized under the MDR and should be consulted for specific requirements. Ensure that you are using the latest versions of these standards and that they are referenced in the European Commission’s list of harmonized standards.

5. Guidance Documents

• MEDDEV Guidance Documents: The European Commission’s MEDDEV documents provide additional guidance on specific aspects of compliance, such as clinical evaluations and risk management.

Key Considerations

• Up-to-Date Standards: Always use the most recent versions of standards and regulations.
• Consult Notified Body: Your Notified Body can provide guidance on which specific standards are applicable to your device.
• Documentation and Compliance: Ensure that your technical documentation reflects compliance with these standards and regulations.

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