MAIN ORGANIZATIONAL AND ECONOMIC VECTORS OF IMPLEMENTATION OF CERTIFICATION SYSTEMS FOR MEDICAL DEVICE MANAGEMENT

Abstrakt

INTRODUCTION. Implementation of certification systems for quality management (QMS) for medical devices in Ukraine, in particular the ISO 13485 standard (in Ukraine it is valid as DSTU EN ISO 13485:2018), is a critically important requirement for manufacturers, importers and distributors who seek to work in accordance with technical regulations and European standards. This standard is harmonized with EU requirements and provides a presumption of conformity with the technical regulations of Ukraine.

THE PURPOSE OF THE STUDY is to substantiate the main organizational and economic vectors of implementation of certification systems for medical device management.

THE HYPOTHESIS OF THE STUDY is to investigate the organizational and economic vectors of implementation of certification systems for medical device management.

RESEARCH METHODS: generalization, deduction, induction, analysis and synthesis, abstraction.

CONCLUSIONS. Accession to the European Union opens up new political and economic opportunities for the country and contributes to improving the quality of life of every Ukrainian. The implementation of European standards and best practices will ensure modern medicine, transparent conditions for business and reliable protection of citizens' rights. Analysis of the institutional framework revealed that Ukraine has a multi-level regulatory model, within which the ISO 13485 standard, through a mechanism, actually acquires the status of mandatory for manufacturers. The transition of the Ukrainian medical industry to more stringent requirements, similar to the EU Regulations (MDR/IVDR), is justified, which is due to the strategic course towards European integration and the opening of access to the European Union market.

KEYWORDS: harmonization of national legislation with European standards; European standards; implementation of certification systems for medical device management; quality management systems.