A sole authorised representative established in a Member State, with a written mandate. Without it the device cannot be placed on the Union market at all.
Ukraine
Ukraine is rebuilding its rules on the MDR. The EU route just became cheaper to add
On 10 June 2026 the Ukrainian government adopted two technical regulations: Resolution 759 on medical devices, built on Regulation (EU) 2017/745, and Resolution 758 on in vitro diagnostic medical devices, built on Regulation (EU) 2017/746. For a manufacturer that has to comply at home anyway, the marginal cost of preparing for the European market has fallen.
What the alignment changes for a manufacturer
The domestic file a Ukrainian manufacturer will have to maintain is being rebuilt around the same structure the MDR uses: classification rules, technical documentation, clinical evaluation, post-market surveillance and vigilance. Work done for the domestic regime therefore stops being work that only serves the domestic market.
The runway is long and it has layers that most summaries flatten. Both technical regulations are put into effect from 31 December 2030. Under Resolution 759, certificates issued under the 2013 technical regulations, Resolutions 753 and 755, that are valid as at that date remain valid until they expire but for no longer than twelve months from the date the new regulation is put into effect, and for those same twelve months devices meeting the 2013 requirements may still be placed on the market or put into service. In Resolution 758 the date of 31 December 2031 means something different: it is the day subpoints 2 to 9 of point 27 are put into effect, not a transitional window for placing diagnostics on the market. A handful of provisions in both acts are tied to a different event altogether, the day Ukraine becomes a Member State of the European Union.
Recognition runs one way, and that has to be said plainly
Conformity assessment carried out in the European Union continues to be recognised in Ukraine under the existing framework. The reverse is not yet true. The agreement on conformity assessment and acceptance of industrial products, discussed in Ukraine as an industrial visa-free arrangement, covers priority sectors that do not include medical devices.
For now, a Ukrainian certificate does not open the Union market and a Ukrainian manufacturer remains a manufacturer established outside the Union for the purposes of the MDR. A CE certificate, by contrast, serves both markets. That asymmetry is the strongest commercial argument for putting the European route first rather than second.
What a European route requires on top of the domestic file
For everything above class I, a certificate from a body designated under the MDR, with the right scope codes for the devices concerned.
Actor registration and a single registration number, then device data in EUDAMED. The obligations in Articles 27 and 29 apply from the dates set out in Article 123(3).
Representative and importer details on the label, and documentation available in an official Union language determined by the Member State concerned.
For manufacturing sites in Ukraine, an honest assessment of audit access, supply continuity and the notification duty under Article 10a where supply could be interrupted.
Questions from Ukrainian manufacturers
Should we wait for the sectoral agreement to cover medical devices?
There is no announced date for that, and the priority sectors named so far do not include devices. A plan that depends on it is a plan without a timetable.
Can a notified body audit our site during the war?
That is assessed case by case, with the body and its insurer. It is one of the first questions to ask, because it shapes the whole schedule.
Does a CE certificate help us at home?
European conformity assessment results continue to be recognised in Ukraine under the current framework, so the same certificate supports both markets. Confirm the recognition route for your specific device before relying on it commercially.
Official basis checked on 15 August 2026
The Ukrainian technical regulations were checked in the official legal register of the Verkhovna Rada. The MDR provisions cited on this page were checked against the EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · Resolution 759 of 10 June 2026, medical devices → · Resolution 758 of 10 June 2026, in vitro diagnostics →
Plan the EU route
Map the work before committing to a certification timeline.
Review the service scope for manufacturers established outside the Union, or start with the market entry hub to see the route end to end.