Проблеми класифікації, оцінки безпечності та управління ризиками медичних виробів з біологічно активними речовинами

The aim of the work was to investigate scientific and technical approaches for ensuring biological safety and classifying medical devices containing biologically active substances in the context of new international standards and regulatory requirements. Materials and methods. The study includes an analysis of the current regulatory landscape, including Regulation (EU) 2017/745, international standards ISO 10993, and guidance documents from the Medical Device Coordination Group (MDCG). Classification specificities of medical devices containing biologically active substances were examined, taking into account their mechanism of action. Approaches to biocompatibility assessment and systemic risk analysis were reviewed using the Weight of Evidence (WoE) concept. Results. Key differences between the classification of medical devices under Directive 93/42/EEC and Regulation (EU) 2017/745 were analysed. The study identified specific aspects of biocompatibility assessment for medical devices containing biologically active substances, as well as challenges related to the standardisation of their physicochemical characteristics. Examples were provided to distinguish between medicinal products and medical devices based on their mechanism of action. The implementation of modern methods for assessing medical devices' safety and regulatory status was also examined. Conclusions. The new regulatory requirements, in particular the provisions of Regulation (EU) 2017/745, significantly impact the classification and biological safety assessment of medical devices containing biologically active substances. An adaptation of the biocompatibility assessment methods was proposed, considering modern trends and the "Weight of Evidence" approach. The study highlights the need to update Ukraine's national regulatory framework to align with European standards and to introduce clearer methodological approaches to differentiate between medicinal products and medical devices