PRODORTH SPINE

EU Medical Devices Regulation 2017/745 - MDR

MDR (2017/745) is a regulation on clinical research and sale of medical devices.

The purpose of this regulation is to determine the procedures and principles regarding the protection of the health of patients, users, and other persons, as well as ensuring high quality and safety standards in medical devices.

​​​​​​​As it is known, the Medical Device Regulation (MDR) No. 2017/745 (EU) entered into force by being published in the EU Official Journal Gazette on 25 May 2017. It was foreseen to be implemented by 26 May 2020, but due to the coronavirus pandemic, the date of implementation and the repeal date of the current directives (MDD) have been updated to 26 May 2021.

PRODORTH maintains a “sustainable quality understanding" for all our staff in terms of preparations for MDR process. In order to fulfill the new obligations of MDR, we try to combine "teamwork" and "quality awareness" to ensure the safety of our products.