THE IMPACT OF THE ADOPTION OF THE REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON THE LEGISLATION OF UKRAINE

Анотація

This work analyzes changes in the requirements of international European legislation on medical devices, in particular the procedure for conformity assessment of medical devices in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. As a result of the research, the established consequences of the adoption for the Ukrainian market, manufacturers of medical devices and consumers are caused by the possible actions to harmonize Ukrainian legislation and EU legislation.It is argued that the development of a system of principles and approaches for the implementation and application of European requirements in the activities of regulators of the medical device market, including conformity assessment bodies, will reduce the risk of manufacturing substandard products, which will significantly increase the safety of medical devices.Keywords: Medical devices, Technical regulation, Directive, ACCA agreement, European Union, Legislation of Ukraine.

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