The Clinical Evaluation Report (CER) is essential for achieving Medical Device Regulation (MDR) compliance in medical devices. It involves a thorough literature review, comprehensive risk management, and critical assessment of clinical data. The CER must demonstrate conformity with state-of-the-art and be prepared by qualified, independent evaluators. Continuous updates and post-market surveillance ensure ongoing compliance and patient safety. This document plays a vital role in obtaining MDR approval, allowing medical devices to meet regulatory requirements, while delivering safe and effective healthcare solutions. Manufacturers who adhere to these essentials can navigate the complex regulatory landscape, providing devices that positively impact patient outcomes.