Akademik Veri Yönetim Sistemi
Journal of Health Systems and Policies, cilt.5, sa.1, ss.53-68, 2023 (Hakemli Dergi)
Neuromodulation
techniques (NIBS) and devices that have emerged in the last thirty years
continue to develop rapidly. NIBS, which initially appeared to be effective
only for the treatment of some neurological diseases, have been found to be
effective in increasing 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, individual use
of these devices is increasing rapidly in many countries; on the other hand,
many research studies on the effectiveness, safety, and new usage areas of the
techniques continue. The production, placing on the market, and use of all
these 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 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 prevent patients from benefiting from these treatments.
In this
study, the old and new regulations are analyzed 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.