Ukraine desk

Market access for medical and electrical devices in Ukraine.

Regulatory support for medical and IVD devices, electrical equipment in Ukraine — from the technical file and conformity assessment to national registration.

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TR 753/755/759 · MD TR 754/758 · IVD TR 1067 · LVD TR 1077 · EMC TR 139 · RoHS TR 355 · RED TR 62/1630 · machinery TR 804 · ecodesign

TR — Ukrainian technical regulation.

Scope of work

Several regulations, one Ukrainian file.

The electrical pack

Whichever Ukrainian TRs the product actually needs — low voltage, EMC, RoHS, radio, machinery, ecodesign. A laptop with Wi-Fi is usually the first four. Same desk, one file.

Technical file

We map the file you already have onto the Ukrainian texts, complete the Ukrainian file and the local papers. A CE pack helps if you have one; it is not required.

National step

Declaration of conformity, local operator papers, and the Ukrainian procedure through to placing the product on the market. Laboratory tests stay with the laboratory.

Regulation

The TRs that apply to the product.

A notebook with Wi-Fi is typically low voltage, EMC, RoHS and radio. Other products take a different mix of the same list. We map whatever file you already have onto the Ukrainian texts that apply. A CE certificate is not required.

Ecodesign and the energy label

TR 804 is the framework. Separate resolutions then set energy-use rules for listed types — vacuums, computers, lighting, white goods and others. Not every electrical product is listed.

The energy label on the shop sticker is a different set of rules. Household appliances that are listed usually need one; many laptops do not. We check whether the type is listed and whether your existing file already covers it. We do not invent laboratory energy figures.

Before you start

What is usually needed.

Whatever you already have is enough to see what is missing. A CE pack helps if you have one; it is not required.

The product Model, what it is used for, how it is powered, and whether it has radio.
EU declaration The current declaration of conformity, if you have one, and which rules it cites.
Evidence Safety, EMC and radio test reports where they apply, plus the RoHS file or supplier statements.
Labelling Rating plate, instructions, and an energy label if this product type uses one.