What is (EU) 2017/745 Medical Device Regulation (MDR)?

(EU) 2017/745 Medical Device Regulation (MDR) was published in the official journal of the European Union on 05.05.2017 and was put into practice as of 26.05.2020. The regulation in question was published in the official gazette in Turkey on 02.06.2021. With the new regulation, the requirements and responsibilities of all economic operators operating in the field of medical devices have been defined in detail, and stricter requirements have been imposed on both manufacturers and notified bodies, especially regarding personnel and processes, in the context of conformity assessment services. In this context, (EU) 2017/745 Medical Device Regulation (MDR) requires certification of some medical devices (Class I reusable devices) that did not previously need to receive certification services by any approved organization, and also the risk class of some devices has been increased and stricter and more requirements have been set for the relevant devices. In addition, within the framework of conformity assessment, the clinical evaluation processes of medical device manufacturers and their clinical research responsibilities within this scope have been clarified and the scope of post-market surveillance activities have been detailed. The inspection / evaluation scopes and durations for the conformity assessment processes to be carried out within the scope of the new regulation have also increased.