This Resolution of the Cabinet of Ministers of Ukraine No. 759 dated June 10, 2026, approves a new Technical Regulation on medical devices, which significantly updates the requirements for the safety and quality of products on the market. The document is aimed at harmonizing Ukrainian legislation with European standards, which provides for the implementation of modern identification and surveillance systems. The Resolution also contains a detailed action plan covering the period until 2030 for the gradual transition to the new regulatory rules.
**Structure and main provisions:**
The Resolution consists of a regulatory part, an implementation action plan, amendments to the list of products subject to market surveillance, and a list of acts that are becoming void. The main change consists in abandoning the outdated 2013 regulations (No. 753 and No. 755) in favor of a single comprehensive document. An important feature is the transition period: the new requirements enter into force on December 31, 2030, however, preparations for them begin much earlier.
**Key aspects for implementation:**
* **Transition period:** Until December 31, 2030, the circulation of devices that comply with the old regulations is permitted, provided there are no significant changes in design and no risks to health.
* **UDI system:** A Unique Device Identification (UDI) system is being implemented, which will allow for the tracking of products at all stages of circulation.
* **National database:** A comprehensive electronic system is being created, which will consolidate the registration of manufacturers, clinical investigations, post-market surveillance, and state market surveillance.
* **Market surveillance:** Functions of control over medical devices are assigned to the State Service of Ukraine on Medicines and Drugs Control (the State Medicines Service), which will require business entities to comply with new reporting and certification procedures.
