Abstract

Reimbursement policies for medical devices in EU and health technology assessment (HTA) are at the heart of this article. Their development is the result of coordination of many institutions - the European Commission, the European Parliament, the government, agencies and their importance is key. The financial instruments in the reimbursement policies for medical devices in the EU are becoming more and more avant-garde, with the key importance of those from donations or crowdfunding, fundraising for patient organizations and others. The authors emphasize the role of public administration in the formation of effective reimbursement policies for medical devices in line with trends and good practices in the field of medical devices and active participation in the processes, together with European institutions and programs. The authors of the article discuss alternative and innovative approaches, budget impact assessment and reimbursement policies for medical devices in Europe and the EU based on HTA. The authors focus their research on the European experience, the synchronization with European regulations, the harmo-nization of management methods and the role of HTA in the field of management of public funds by institutions and public organizations in Bulgaria. The authors of the publication examine the experience of international institutes in the field of HTA-experience of Great Britain, Germany, France, given the benchmark they have and the need to educate health professionals, administrators, companies in Bulgaria.

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