Labeling of medical devices intended for showing, demonstrations at the place of fairs, exhibitions.

23.09.2020

Other news

11.06.2025

Practical guide for the use of European Medical Device Nomenclature

Manufacturers operating under the (EU) 2017/745 Medical Device Regulation (MDR) and (EU) 2017/746 In Vitro Diagnostic Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling.   To support consistent and compliant application, MedTech Europe released a practical guide for the use of the […]

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28.02.2019

Legalization of import products for the Ukrainian market of medical products

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 […]

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19.08.2024

Formation of a technical file for medical devices

The program of the event is available only on Ukrainian

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