Requirements for clinical evaluation of medical devices in the european union and ukraine legislation

ABSTRACT. Within the framework of the association agreement between Ukraine, on the one hand, and the European Union, the European Atomic Energy Community and their member states, on the other hand, Ukraine has committed itself to gradually achieve compliance with EU technical regulations and systems of Standardization, Metrology, accreditation, conformity assessment work and market surveillance of the EU and has committed itself to adhere to the principles and practices set out in current EU decisions and regulations. Aim. To carry out a comparative analysis of approaches to the technical regulation of medical devices and their clinical evaluation. Materials and methods. An analysis of EU and Ukrainian regulatory acts in the field of technical regulation of medical devices and their clinical evaluation was carried out. Results. The provisions of the EU regulation governing the issue of clinical evaluation of medical devices are considered. Attention is focused on the approaches and requirements of the EU in the field of regulation of medical devices regarding their clinical evaluation, as well as on regulatory and legal aspects of the regulation of clinical evaluation of medical devices in Ukraine. The authors made proposals for improving the legal regulation of clinical evaluation of medical devices in Ukraine in accordance with EU requirements, in particular, the requirements for the clinical evaluation plan and the report on its results. Conclusions. The regulatory framework for conducting clinical evaluation of medical devices needs to be improved. When developing and implementing it, it is necessary to take into account the following aspects: new definitions of terms, improvement of the procedure for conducting clinical evaluation of medical devices, mandatory and requirements for post-monitoring clinical observation and postmonitoring supervision. Keywords: medical devices, clinical assessment, clinical data, post-monitoring clinical observation, post-monitoring supervision.