We are excited to be the first organization to obtain the CE certificate in accordance with the MDR regulation among surgical instrument manufacturers in the world. We have taken a step that sets standards of trust and quality in the healthcare sector. What is MDR? (EU) 2017/745 Medical Device Regulation (MDR) was published in the official gazette of the European Union on 05.05.2017 and has been implemented as of 26.05.2020. MDR is a regulation developed to ensure the safety and effectiveness of medical devices. Compliance with the MDR is an important responsibility for medical device manufacturers, importers and service providers. The cost and complexity of complying with these regulations poses a significant challenge for businesses . The CE certification process may initially seem daunting and costly. But deciding and starting to manage this long and complex process correctly is actually leaving half of the difficulties behind. Analyzing the needs correctly allows you to save time and money and reduce errors and risks. First of all, we had to define the risk class of the medical device (surgical hand tools) we produce and the required tests . In the technical file preparation phase, it is necessary to design our products and then make sure that this technical file prepared with the test results meets the EU requirements. After the selection of the accredited, ie authorized body known as the Notified Body, the audit preparations are made. In fact, the preparation that needs to be done is to make ISO 13485 requirements and traceability a way of life. In fact, getting support from a training and consultancy organization during the preparation phase of this process plays a facilitating role in determining your road map. However, the point to be considered in this selected training and consultancy firm is that it should be a staff of experts , success-oriented and capable of taking quick action, reliable and cost-effective .