How We Helped a German IVD Manufacturer Obtain Registration on the Third Attempt
Situation:
In 2023, we were approached by a company from Germany manufacturing in vitro diagnostic (IVD) kits. They had already received two refusals from the Ministry of Health of Ukraine due to inconsistencies in their technical documentation.
Solution:
We conducted a full audit of the dossier, adapted the IFU to comply with the requirements of Technical Regulation No. 754, translated and finalized the documentation, and submitted it electronically via the eHealth portal while handling communication with the authorities.
Result:
The client received a positive registration decision in just 20 days.
Conclusion:
✅ This case shows how essential precision and experience are when working with regulatory documentation. We’re ready to step in — even when others say it’s too late.
How We Helped an Italian Manufacturer Obtain Registration on the First Try
Situation:
In 2024, we were contacted by a company from Italy entering the Ukrainian market for the first time with a PCR diagnostic kit. The client had no prior experience with Ukrainian technical regulations and was unsure what documents were required.
Solution:
We prepared a complete documentation package in accordance with Technical Regulation No. 754, including the IFU, Declaration of Conformity, labeling draft, Authorized Representative Agreement, and additionally — a classification decision issued by a Conformity Assessment Body. All documents were submitted via the eHealth portal, and we handled communication with the Ministry of Health on the client’s behalf.
Result:
After 16 days, the client received a positive decision from the Ministry of Health of Ukraine — with no remarks or additional requests.
Conclusion:
✅ This case shows how essential it is to prepare properly for your first registration. We take on the responsibility and help manufacturers complete the process as quickly as possible.
How a Manufacturer Lost 5 Months Due to Incorrect Risk Classification
Situation:
In 2024, a foreign manufacturer attempted to register a medical device in Ukraine under Class I to simplify the process. However, the product clearly fell under Class IIa and required Notified Body involvement according to Technical Regulations No. 753 and No. 754.
Solution:
After the initial application was rejected, we were asked to help. We conducted a risk-based classification assessment, revised the conformity documentation, involved a notified body, and prepared a fully compliant dossier.
Result:
The device was successfully registered, but only after a 5-month delay caused by the initial misclassification.
Conclusion:
❌ Misclassifying the risk class may save time at first glance — but it leads to rejections, delays, and reputational risks. Always follow the proper regulatory path.
When a Non-Medical Product Was Submitted as a Medical Device
Situation:
In 2023, a distributor submitted a consumer product for registration as a Class I medical device in Ukraine. Upon review, it turned out the product didn’t meet the legal definition of a medical device under Technical Regulation No. 753 — it lacked a clear medical or diagnostic purpose.
Solution:
We advised the client to withdraw the application and reclassify the product. It was later successfully launched under general market regulations as a non-medical item.
Result:
Although the product reached the market, time and resources were lost due to the wrong classification approach.
Conclusion:
❌ Not every product belongs to the medical field. A precise regulatory assessment at the beginning helps avoid wasted effort and protects your company’s credibility.