After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory documents of the health sector. It should be noted that affixed CE mark at the product, as well as availability documents, which confirm compliance to the European Directives on medical devices, does not authorize placement of the product on the Ukrainian market without passing the national conformity procedure.

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