Understand Requirements: Familiarize yourself with the MDR 2017/745, specifically sections related to Class D medical devices, to ensure a clear understanding of the regulatory requirements.

Documentation Preparation: Time required to prepare and organize all necessary documentation, including the Design Dossier, clinical evaluations, risk management, and Quality Management System (QMS) documentation.

Regulation Familiarization: Thoroughly review the EU Medical Device Regulation (MDR) 2017/745 to understand the requirements for Class D devices.

MDR 2017/745: This is the primary regulation governing medical devices in the EU. Ensure compliance with all relevant articles, especially those relating to high-risk devices (Class D), including clinical evaluation, risk management, and post-market surveillance.

Ongoing Monitoring: Continuously monitor the performance and safety of your device once it is on the market.

Familiarize Yourself with MDR 2017/745: Understand the EU Medical Device Regulation (MDR), which governs the requirements for medical devices in the EU. Focus on specific provisions related to Class D devices, which are considered high-risk.

Implement a System: Develop and maintain a robust post-market surveillance system to monitor the device's performance and safety once it is on the market.

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.