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

Abstract. In modern conditions of development of medical technologies, software becomes an integral part of medical devices and plays one of the key roles in modern medicine. Software provides the functioning of medical equipment, contributes to the automation of the processes of diagnostics, treatment and monitoring of patients' health.

Aim. To analyze the regulatory and legal regulation of medical device software in Ukraine and the EU, to identify key differences and problematic aspects in the classification of software as a medical device, and to outline possible ways to improve regulatory approaches to ensure the safety and effectiveness of such products.

Materials and Methods. An analytical review of the regulatory and legal acts of Ukraine and the European Union regulating the circulation of medical devices, in particular software that is their integral part or an independent medical device, was conducted.

Results and Discussion. In recent years, in the field of conformity assessment of medical devices, the number of cases when software becomes an integral part of medical devices or exists as a stand-alone medical device has been increasing. Ukrainian legislation regulates the introduction of such products into circulation in accordance with the Law of Ukraine "On Technical Regulations and Conformity Assessment" and Resolutions of the Cabinet of Ministers No. 753, 754, 755. However, in the technical regulation on medical devices (Resolution No. 753) remains uncertainty in the classification of risks for software as a stand-alone medical device, which creates difficulties in conformity assessing. The European Regulation (EU) 2017/745 has eliminated some of these uncertainties by introducing new concepts such as “compatibility”, “interoperability” and requirements for software, including its security and compliance with modern IT standards. Clear rules for classifying software by risk level have been defined (Rule 11), which allows it to be assigned to classes from I to III depending on the impact on the patient’s health. However, the question of a possible overestimation of the risk class for software in its own right remains open due to difficulties in determining the severity of possible consequences. The solution may be an approach that takes into account the impact of the software on various systems of the body, which is, in our opinion, more reasonable.

Conclusions. The regulation of software as a medical device has been significantly improved in the EU Regulation 2017/745. It is necessary to improve the risk classification methodology for software in its own right in order to avoid unjustified overestimation of the risk class and reduce subjectivity in decision-making. A promising direction is to link the risk class of software to specific physiological systems of the body, which will allow a more objective assessment of the level of potential danger and avoid unnecessary complication of conformity assessment procedures. Thus, the TR currently in force in Ukraine needs to be revised, improved and harmonized in accordance with existing international approaches.

Keywords: medical devices, software, technical regulations.

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 15.01.2015 No. 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 02.10.2013 No. 753 “On approval of the Technical Regulations on medical devices”].

3. Постанова Кабінету Міністрів України від 02.10.2013 року № 754 «Про затвердження Технічного регламенту щодо медичних виробів для діагностики in vitro». [Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 754 “On approval of the Technical Regulations on medical devices for in vitro diagnostics”].

4. Постанова Кабінету Міністрів України від 02.10.2013 року № 755 «Про затвердження Технічного регламенту щодо активних медичних виробів, які імплантують». [Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 755 “On approval of the Technical Regulations on active implantable medical devices”].

5. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

6. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

7. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

8. Guidance document MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR October 2019.

9. IMDRF/SaMD WG/N12FINAL:2014 "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations. 18 September 2014.

10. ДСТУ EN ISO 13485:2018 Медичні вироби. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT). [DSTU EN ISO 13485:2018 Medical devices. Quality management system. Regulatory requirements (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT)]. 11.IEC 62304:2006 – Medical device software – Software life cycle processes.

12. Guidance document MDCG 2019-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

13. WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, WHO Medical Device Technical Series, 2017.

14. FDA Software as a Medical Device (SaMD): Clinical Evaluation, Guidance for Industry and Food and Drug Administration Staff, 2017.

Стаття надійшла до редакції 05.06.2025 р.

Received June, 5, 2025.