In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]
Recognition of European certificates for medical devices in Ukraine: impact on the market and manufacturers
Following recent events, we conducted two webinars on November 21st and 24th, 2023, aimed at elucidating the procedures and benefits of recognition of CE certificates for medical devices in Ukraine. The first speaker was Viktoriia Moroz, a Key Account Manager, who discussed legislative requirements, the extension of the transitional period until December 31, 2028, and the procedure for recognition of EC certificates under the new EU MDR and IVDR Regulations.
The second webinar was conducted by Maksym Bagrieiev, managing partner, who thoroughly examined the impact of extending the transitional period from MDD to MDR on Ukrainian certificates, the procedure for recognizing CE MDR and IVDR certificates, and other key aspects under European regulations.
Since 2016, Ukraine has been conducting the recognition procedure that has gained significant demand among manufacturers due to its transparency and absence of mandatory audits. It is worth noting that the recognition procedure does not provide an exchange of European certificates for Ukrainian ones, but allows for conformity assessment through documentation, facilitating manufacturers’ entry into the Ukrainian market.
An important aspect of recognition is the impact of changing the classification of medical devices due to the transition from MDD to MDR in the EU. The updated rules and altered classifications have posed a challenge for many manufacturers, but the recognition considers these changes and evaluates them carefully.
These webinars have been significant events for authorized representatives in Ukraine and foreign manufacturers interested in participating in the Ukrainian medical product market. Webinars provided an opportunity to obtain information about recognition procedures and the impact of European regulations on legalization procedures in Ukraine, which will contribute to the further development of the country’s medical market.
Our events are conducted in Ukrainian and English to ensure that every participant can access valuable information. We believe in accessibility and diversity and strive to ensure that our webinars are structured in a way that allows every participant to conveniently acquire the desired information.
If you have any questions for our speakers, please feel free to reach out.
You can send your inquiries to our email: info@cratia.ua.
Additionally, you can call us at: +38 (068) 064-78-31, where you will receive immediate consultation regarding medical devices.
With respect and care,
The Cratia team
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