Ukraine desk
Regulatory support for medical and IVD devices, electrical equipment in Ukraine — from the technical file and conformity assessment to national registration.
TR — Ukrainian technical regulation.
Scope of work
We classify the device, complete the Ukrainian file, draw up the declaration of conformity, involve a designated body when the class requires it, and take the file through the national register until the reviewer’s comments are closed.
Under TR 753, 754 and 755: intended purpose, classification, essential requirements, risk management, labelling, instructions for use, and quality-system evidence.
For manufacturers and distributors: what Ukraine asks for to place a device on the market, how class changes the route, what goes in the file, and when a declaration or a designated body is needed.
Regulation
Today’s Ukrainian regulations follow the old EU medical-device directives. The next pair, already adopted, follows the current EU medical device and IVD regulations. If you already have an EU file, it is a useful starting shape — it still has to be mapped onto the Ukrainian texts. A CE certificate is not a Ukrainian requirement.
Cabinet resolutions of 2013. TR 753 is medical devices. TR 754 is in-vitro diagnostics. TR 755 is active implants. The route depends on class: a declaration and quality-system evidence, or a designated body for higher risk.
Adopted on 10 June 2026. They start to apply at the end of 2030 and then replace the three 2013 texts. TR 759 covers medical devices, including today’s implants. TR 758 covers IVD. You can already structure the file the way those new texts will expect, so the switch is preparation, not a restart.
Before you start
It depends on the device and the class. Enough to start: a short description, whatever file you already have, and the current labelling.