For manufacturers
You manufacture medical devices or IVD and need access to the Ukrainian market. Support covers classification, technical documentation, conformity assessment and national registration.
Who we help
One Ukraine desk, two typical needs.
Focused support for manufacturers entering the Ukrainian market and for consultancies that need a reliable Ukraine regulatory partner.
For consultancies
You already advise manufacturers in Europe and need reliable Ukraine regulatory support. We can act as your Ukraine regulatory desk for MD and IVD projects.
White-label if you want it: you keep the client and the outward face of the file. Classification, the technical file, the designated-body route and reviewer correspondence stay under your brand — unless you ask the desk to step in directly.
How a project starts
A letter first, then the route.
01
Write
Product, class if known, and what you already have.
02
Review
Gaps for the Ukrainian route. A complete file is not required to start.
03
Route
Agree the path: declaration, designated body where needed, national registration.
04
File
Technical file, reviewer correspondence, comments closed.
Scope of work
From the technical file to registration.
The core work stays close to the route: classification, documentation, conformity assessment and the national stage.
Core service
Ukraine registration
Support with registration of medical devices and IVD under local Ukrainian legislation — from classification and technical documentation to the declaration of conformity, QMS evidence, designated body involvement where required, and national registration. Reviewer comments are followed through until the file is accepted.
Core service
Technical files for the Ukrainian market
Preparation of technical files for medical devices and IVD under TR 753, 754 and 755, including device description, intended purpose, classification, essential requirements, risk management (ISO 14971), labelling and IFU, and QMS evidence.
Additional support
Training for manufacturers and distributors
Training for manufacturers and distributors on Ukraine MD and IVD registration — what is needed to place a device on the market, how the classification affects the route, what documentation is required, and when QMS evidence, a declaration of conformity or a designated body are needed.
Additional support
EMC / LVD / RoHS / RED
Technical files and registration in Ukraine under the EMC, LVD, RoHS and RED technical regulations, covering electromagnetic compatibility, low-voltage equipment, restriction of hazardous substances and radio equipment.
Regulation
Ukraine today. Transition already underway.
Ukraine's current technical regulations are based on the EU directives, while the next generation follows MDR/IVDR. This means that the structure of a Ukrainian technical file is already familiar to companies working with MDR/IVDR documentation.
Ukraine now: TR 753 / 754 / 755
The current Ukrainian route is based on the 2013 Cabinet resolutions. TR 753 covers medical devices (MDD), TR 754 covers in vitro diagnostics (IVDD), and TR 755 covers active implants (AIMDD).
The conformity-assessment route depends on the device class. Depending on the class, the process may involve a declaration of conformity and QMS evidence, or a designated conformity-assessment body for higher-risk devices.
The national stage includes registration of the economic operator and the device in the Ukrainian system, followed by communication with the reviewer until the comments are closed.
A typical technical file includes: intended purpose, classification, essential requirements, risk analysis, labelling and IFU, clinical or performance evidence at the level required for the device class, and the QMS under which the device is manufactured.
MDR / IVDR and the next Ukrainian framework
EU 2017/745 (MDR) and 2017/746 (IVDR) keep the same core structure — classification, GSPR, technical documentation, QMS and economic operators — but add significantly more post-market requirements, including UDI, PMS/PMCF and vigilance. They also introduce stricter responsibilities for the person responsible and importer, as well as a new classification approach, particularly for IVD (A–D).
On 10 June 2026, Ukraine adopted TR 759 for medical devices, based on the MDR, and TR 758 for IVD, based on the IVDR. They will apply from 31 December 2030 and will then replace TR 753/754/755.
For manufacturers, this means that transition planning can already use the MDR/IVDR framework: new classifications, GSPR, UDI, SRN and a national database designed to connect with EUDAMED.
Today
MD
TR 753
TR 759 / MDR
IVD
TR 754
TR 758 / IVDR
AIMDD
TR 755
TR 759 / MDR
Practical point
Documents and authorised representative
For market access in Ukraine, the key requirement is the relevant technical documentation together with the required local documents.
- A CE certificate, an ISO 13485 certificate or a Free Sales Certificate is not required.
- Foreign manufacturers appoint an authorised representative in Ukraine.
What is usually needed.
The starting package depends on the device and its class. These are the documents and inputs typically relevant to the route.
Device information
Device description and intended purpose.
Classification
Existing classification and rationale, where available.
Technical documentation
Existing technical file and supporting evidence.
QMS information
Quality-management documentation relevant to the route.
Labelling and IFU
Current labelling, instructions and related materials.
Operator details
Manufacturer and economic-operator information.
About
Ukraine desk
Around ten years of regulatory work on medical devices and IVD. The practice is Ukrainian technical regulations 753, 754 and 755 — the national texts based on MDD, IVDD and AIMDD — and the coming UA TR 758/759 aligned with MDR/IVDR.
The desk covers classification, technical and QMS documentation, designated-body assessment where required, national registration, and correspondence with reviewers until comments are closed.