For Class B medical device CE certification, the following standards and regulations are applicable:

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

• General Regulation: This is the primary regulation that governs the CE certification process for all medical devices, including Class B devices. It outlines general safety and performance requirements, clinical evaluation, risk management, and post-market surveillance.

2. ISO 13485:2016:

• Quality Management System (QMS): This standard specifies requirements for a QMS to ensure consistent design, development, production, and delivery of medical devices that are safe and effective.

3. ISO 14971:2019:

• Risk Management: This standard provides guidelines for the application of risk management to medical devices, including identifying, assessing, and mitigating risks.

4. IEC 60601 Series:

• Electrical Safety and Performance: For devices with electrical components, relevant parts of this series of standards cover the safety and performance of medical electrical equipment.

5. ISO 10993 Series:

• Biocompatibility: This series provides guidelines for evaluating the biocompatibility of medical devices, including testing for cytotoxicity, sensitization, and irritation.

6. ISO 15223-1:2016:

• Symbols: This standard specifies symbols to be used on labels, labeling, and instructions for use to ensure clear and consistent communication of device information.

7. ISO 14155:2020:

• Clinical Investigation: Provides guidelines for the planning, conduct, and reporting of clinical investigations of medical devices.

8. IEC 62366-1:2015:

• Usability Engineering: Provides guidance on usability engineering processes to ensure medical devices are designed with user safety in mind.

9. Harmonized Standards:

• List of Standards: The European Commission publishes a list of harmonized standards that align with the MDR. These standards are accepted as demonstrating compliance with specific MDR requirements.