News

Under the EU Medical Device Regulation (EU MDR 2017/745), every manufacturer placing a medical device on the EU market must implement a comprehensive post-market...

Over the past two weeks, several manufacturers contacted us regarding the change of their Authorised Representative (AR) in Ukraine. In most cases, the reason...

1. Multi-level regulation By definition, a medical device must comply with the technical regulations in the field of medical devices (in Ukraine: TRs No....

In 2025, Ukraine is actively preparing for a major reform of its regulatory framework for medical devices. The main objective is to align national...

All medical devices intended for placing on the Ukrainian or EU market must undergo clinical evaluation. This does not always mean conducting a clinical...

Introduction: War Doesn’t Stop the Market Despite full-scale war and ongoing economic challenges, Ukraine’s medical device market remains resilient and active. In 2025, procurement,...

In 2024, Ukraine made further progress in digitalizing regulatory procedures for medical devices. The Ministry of Health and the State Service of Ukraine on...

In 2023, Ukrainian healthcare institutions increased their focus on infection prevention and control. This trend was reflected in the rising demand for disposable instruments,...

Despite growing geopolitical instability in early 2022, public procurement of medical devices in Ukraine remained active. Through the Prozorro system, hospitals and clinics continued...