CERTIFICATION SYSTEMS FOR MEDICAL DEVICE MANAGEMENT: CONCEPT AND INSTITUTIONAL SUPPORT IN THE CONDITIONS OF UKRAINE'S EUROPEAN INTEGRATION

Abstract

This article is dedicated to the study of the essence and institutional framework of certification management systems for medical devices in Ukraine. The paper deconstructs the key concepts within the category of "certification management system". The essence of the definitions of "management system", "quality management system", "certification", "conformity assessment" and "medical device" is explored. The necessity of a clear distinction between such key concepts as "certification" and "conformity assessment" is established, substantiating the recognition of certification as one form within the broader category of conformity assessment. Based on this analysis, the author proposes a definition of a certification management system for medical devices as an integrated socio-technical system that combines the internal processes of an enterprise, regulated by the DSTU EN ISO 13485 standard, with external assessment procedures established within the national regulatory field, which is harmonized with European legislation. The analysis of the institutional framework demonstrates the existence of a multi-level regulatory model in Ukraine, based on framework laws, specialized technical regulations, and harmonized standards. It has been found that the DSTU EN ISO 13485 standard, while formally voluntary, acquires a de facto mandatory status for the legal operation of manufacturers through the "presumption of conformity" mechanism. It is emphasized that further European integration and the pursuit of the "industrial visa-free regime" (ACAA Agreement) require domestic enterprises not only to comply with current Ukrainian norms but also to proactively implement the much stricter principles embedded in the EU Regulations (MDR/IVDR). This transforms the implementation of certification management systems for medical devices in domestic medical industry enterprises from a purely technical task into a comprehensive strategic challenge, necessitating systemic changes at both the state and corporate levels.