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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.
The program of the event is available only on Ukrainian
Read moreSince the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put […]
Read moreThe program of the event is available only on Ukrainian
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