Regulatory Knowledge: Familiarize yourself with the EU Medical Device Regulation (MDR) 2017/745, which governs the certification process for medical devices, including Class B devices.

Document Preparation: Compile all required technical documentation, including device descriptions, design and manufacturing information, risk management, clinical evaluation, and labeling.

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

Adhere to MDR: Ensure that your device continues to meet the requirements outlined in the MDR, including safety, performance, and labeling standards.

Device Description: Detailed description of the device, its intended use, and functionality.

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

Monitor Device Performance: Regularly collect and analyze data on the device's performance in the market.

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.