L.I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety, Ministry of Health, Ukraine (State Enterprise), Kyiv, Ukraine

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.

СПИСОК ВИКОРИСТАНИХ ДЖЕРЕЛ/REFERENCES

1. Закон України «Про технічні регламенти та оцінку відповідності» від 15.01.2015 року № 124-VIII. [Law of Ukraine "On technical regulations and conformity assessment" dated January 15, 2015 № 124-VIII].

2. Постанова Кабінету Міністрів України від 02.10.2013 року № 753 «Про затвердження Технічного регламенту щодо медичних виробів». [Resolution of the Cabinet of Ministers of Ukraine dated October 2, 2013 No. 753 "On approval of the Technical Regulations on medical devices&quot].

3. ДСТУ EN ISO/IEC 17065:2019 (EN ISO/IEC 17065:2012, IDT; ISO/IEC 17065:2012, IDT) Оцінка відповідності. Вимоги до органів з сертифікації продукції, процесів та послуг. DSTU EN ISO/IEC 17065:2019 (EN ISO/IEC 17065:2012, IDT; ISO/IEC 17065:2012, IDT) Conformity assessment. Requirements for bodies certifying products, processes and services.

4. ДСТУ EN ISO/IEC 17021-1:2017 (EN ISO/IEC 17021-1:2015, IDT; ISO/IEC 17021-1:2015, IDT) Оцінка відповідності. Вимоги до органів, що здійснюють аудит і сертифікацію систем менеджменту – Частина 1. Вимоги. [DSTU EN ISO/IEC 17021-1:2017 (EN ISO/IEC 17021-1:2015, IDT; ISO/IEC 17021-1:2015, IDT) Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems – Part 1: Requirements].

5. Наказ МОЗ України від 20.01.2020 № 117 «Про затвердження Переліку національних стандартів, відповідність яким надає презумпцію відповідності медичних виробів вимогам Технічного регламенту щодо медичних виробів, затвердженого постановою Кабінету Міністрів України від 02.10 2013 року № 753». [Order of the Ministry of Health of Ukraine dated January 20, 2020 № 117 "On the approval of the List of national standards, compliance with which provides a presumption of compliance of medical devices with the requirements of the Technical Regulations on Medical Devices, approved by Resolution № 753 of the Cabinet of Ministers of Ukraine dated October 2, 2013"].

6. Order of the Ministry of Health of Ukraine dated October 11, 2017 № 1245 "On approval of the list of national standards, compliance with which provides a presumption of compliance of medical devices with the requirements of the Technical Regulations on Medical Devices" (as amended by Order of the Ministry of Health of Ukraine dated January 20, 2020 № 117).

7. Регламент Європейського Парламент та Ради (ЄС) 2017/745 від 5 квітня 2017 року щодо медичних виробів, що вносить зміни до Директиви 2001/83/ЄС, Регламенту (ЄС) № 178/2002 і Регламенту (ЄС) № 1223/2009 та скасовує Директиви Ради 90/385/ЄЕС та 93/42/ЄЕС (ОВ L 117 від 5.5.2017 р., С. 1). EUR-Lex - 02009R1223-20210823 - EN - EUR-Lex (europa.eu). [Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) № 178/2002 and Regulation (EC) № 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) EUR-Lex - 02009R1223-20210823 - EN - EURLex (europa.eu)].

Стаття надійшла до редакції 09 січня 2024 р.

The article was submitted to the editorial office on January 09, 2024.