POSSIBLE CONSEQUENCES OF RECLASSIFICATION OF NON-INVASIVE BRAIN STIMULATING AS A CLASS III MEDICAL DEVICES IN EUROPE AND ITS REFLECTIONS TO OUR COUNTRY

Abstract

ABSTRACT Neuromodulation techniques (NIBS) and devices that have emerged in the last thirty years are continued to develop rapidly. NIBS, which initially appeared to be effective only for the treatment of some neurological diseases, has been found to be effective in increase the capacities of normal people for education, sports, business life and military fields over time. This has led to the production of home/individual use versions of NIBS devices. On the one hand, the individual use of these devices is increasing rapidly in many countries, on the other hand, many researches on the effectiveness, safety and new usage areas of the techniques continue. The production, placing on the market and use of all this NIBS devices to be used for scientific research, treatment or individual uses are directly or indirectly dependent on the rules and conditions in the Medical Devices Regulation (MDR) of the European Union (EU). Our country also complies with these rules. A new regulation numbered 2022/2347 has been published by the EU for the specification of non-medical product groups included in the Annex XVI of regulation No. 2017/745. NIBS devices, one of the product groups in question, have been subjected to a new classification due to this regulation and this change has caused various objections from all stakeholders related to this field. Objections to the new classification stem from the fact that ethics committees will drastically change their approach to research in these areas, and that these changes involve much more challenging conditions for researchers and device manufacturers than before. As a result of this situation, the main concern has emerged that the limitation of research will lead to the interruption of production and development activities in this field and even to prevent the the patients, from benefiting from these treatments. In this study, the old and new regulations are analysed together and it is aimed to evaluate the appropriateness of the procedure and content of the regulation, its reflections on the field and the criticisms brought to the regulation in the light of scientific data in the field. Based on this assessment, an attempt has been made to provide a perspective to the relevant stakeholders in Turkey, researchers, ethics committees that authorise/supervise research with these devices in line with the EU, and the competent authority that oversees the production, distribution and conformity of medical devices, both on the current situation and what should be. Keywords: Non-invasive neuromodulation, European Union Medical Device Regulation, MDR, Turkish Medicines and Medical Devices Agency (TİTCK)