Changes introduced by the European Medical Device Regulation with number 2017/745 and measurement of adaptation level of medical device manufacturer organizations in Turkey

Differences of (EU) 2017/745 Medical Device Regulation (MDR) from the legislation it supersedes, the success of these differences in supporting previous areas of weakness and awareness of medical device manufacturers in Turkey on these changes and their adaptation level were investigated. Literature review method was used to determine the differences of the legislation and success of these differences to response the critics on previous legislation; in order to determine the awareness and adaptation of the manufacturers, data collection was performed by using a questionnaire. Within the scope of the study, manufacturers of devices covered by the (EU) 2017/745 regulation are included; however, manufacturers of devices in 'Class I other' class are excluded from the scope of the study. It is aimed to reach a sample size which is able to represent 10% of the universe, for the number of data to be collected. According to the results has been detected, (EU) 2017/745 MDR brought sweeping changes along in issues that can be grouped as "rules and definitions"; "parties and expertise requirements"; "traceability, infrastructure and reporting requirements"; "requirements for devices" and "requirements for processes". The new legislation greatly strengthened the weak points of the previous directives; however, it is not sufficient to eliminate the root cause of the criticism directed at the lack of clinical knowledge and expertise by manufacturers, even if the requirements for the "person responsible for the legislation" are fully applied. Also, due to the contradictions in the definition of the nanomaterials used in medical devices that occurs because of the lack of well-established scientific knowledge about the properties and the characterization of nano-materials, it can be said that medical device legislation is still open to improvements in its ability to adapt to new technologies even after MDR. Not in all companies in Turkey manufacturing Class I sterile, Class I with a measurement function, Class IIa, Class IIb and Class III medical devices, the expertise required by the human resource needed to ensure adaptation to regulatory changes can be fully achieved. In some enterprises, people with no expertise in medical device technology can eliminate technical experts by using their knowledge on procedural requirements and some others have technical experts; however, there is a lack of education based on knowledge of legislation in these companies. Trainings on legislation are not a part of the undergraduate or graduate degree programs of technical experts. Education and awareness-raising policy of The Turkey Pharmaceuticals and Medical Devices Agency is considered to be insufficient by the manufacturers. The vast majority of medical device manufacturers in Turkey, at the time of this study performed, has yet to take an action for requirements of (EU) 2017/745 MDR that is going to be carried into action in May 2020. At least one of every 10 medical device manufacturers plans to stop the manufacture of at least one product against the obligations of new legislation requirements and more than half of the manufacturers face high clinical research costs under the new legislation requirements.