Ukraine – new country on European regulatory affairs map

13 July 2020


Ukraine

Blog by Nickolay Romanok, CEO and founder of Archimed Medical
The historical association with the Soviet Union gives believes that Ukraine belongs to the list of countries with a specific and incomprehensible regulatory system. However, since 2015 Ukraine can be proud of the next step towards the harmonisation of national legislation with European Union law. And this step fully covers the medical devices market.

In 2015, the Ukrainian government adopted a decree approving technical regulations for all groups of medical devices: the main group of medical devices; medical devices for the Invitro diagnostic, and for active implantable medical devices, as well. But I would like to present to you in this article, a not so important fact of the industry law adoption. I would like to share with you the result of our fruitful five-year work, which gives a lot of advantages for CE marked medical devices during the process of introduction to the Ukrainian market.

How it was?

After conducting a deep analysis of Ukrainian regulatory and industry legislation, we found several opportunities that would greatly simplify the access of medical products that have a CE certificate to the Ukrainian market. Namely, Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”.

The mentioned article allows you to apply the recognition of conformity assessment results conducted by notified bodies of the European Union. The fundamental base for the recognition of the results of conformity assessment in Ukraine is the relevant recognition agreement between the Ukrainian conformity assessment body and the notified body of the European Union. Recognition agreements lay down the conditions under which one Party (Ukrainian conformity assessment body) will accept conformity assessment results (e.g. testing or certification) performed by the other’s Party (the EU Notified Body) to show compliance with the First Party’s requirements.

During these five years, we have been working to sign such contracts as many as was possible. Each manufacturer with a CE Certificate for a medical device had the opportunity to access to the Ukrainian market without roadblocks.

On the date of publication of this article, we can present a list of European notified bodies that already have signed agreements on recognition of CE certificates with Ukrainian conformity assessment bodies.

The list of such bodies:

Bodies

So, if the CE Certificate issued by above-mentioned notified bodies, manufacturers can share their sales activities to biggest European country – Ukraine. It is very important to have access to the market based on low level expenses for the marketing authorisation procedure.

In the next article you can find the road map, a short review how to apply the procedure for recognising CE Certificates. At the same time, I suppose that it is not interesting for everyone to dive into analytics data of local legislation, so Nickolay will be glad to answer all clarifying questions in personal communication.


We want to thank Nickolay Romanok for his time and sharing his knowledge. Do you want to contribute insights about the medical devices industry for the medical devices industry? Share your story with us via info@medidaldevicescommunity.com or call us on 023-7548660!