EU Authorized Representative for Ukraine: From Technical Regulation 753 to MDR Market Access

Technical Regulation 753 is based on Directive 93/42/EEC

The Technical Regulation on medical devices approved by Cabinet of Ministers Resolution No. 753 of 2 October 2013 states its origin in its first paragraph: "Цей Технічний регламент розроблено на основі Директиви Ради ЄС від 14 червня 1993 р. № 93/42/ЄЕС щодо медичних виробів." [This Technical Regulation has been developed on the basis of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.]

It tells a Ukrainian manufacturer exactly which generation of European law its file was built for. Point 14 divides devices into classes I, IIa, IIb and III under the criteria of Annex 2, whose eighteen classification criteria (points 9 to 26) follow the Directive's eighteen rules. MDR Annex VIII has twenty-two, and the four additional rules were written for products the Directive under-classified, including devices with nanomaterials and devices composed of substances absorbed by the body. A class that was correct under Technical Regulation 753 must be re-derived under Annex VIII before any conformity route is chosen.

The quality of the underlying work is often good. Test reports to harmonised standards, sterilisation validations and biocompatibility data generated for a Ukrainian conformity assessment are reusable evidence. What does not transfer is the structure: Annex II and III technical documentation, the Article 61 clinical evaluation, and the post-market surveillance system MDR expects are organised differently from a Directive file.

Resolution 759 moves Ukraine to the MDR model, from 31 December 2030

On 16 June 2026 the State Service of Ukraine on Medicines and Drugs Control (Derzhliksluzhba) announced that on 10 June 2026 the Government adopted Resolution No. 758, approving a Technical Regulation on in vitro diagnostic medical devices, and Resolution No. 759, approving a Technical Regulation on medical devices. The new medical devices regulation opens: "Цей Технічний регламент розроблено на основі Регламенту (ЄС) № 2017/745" [This Technical Regulation has been developed on the basis of Regulation (EU) No 2017/745].

The timetable matters more than the text. Point 7 of Resolution 759 provides that the new Technical Regulation is brought into effect from 31 December 2030, except points 234 and 235, which take effect from the day Ukraine becomes a Member State of the European Union. Those two points reproduce the free sale certificate mechanism of MDR Article 60, which only a Member State can operate. The transitional provisions also allow conformity documents issued by Ukrainian designated bodies under Technical Regulation 753 and valid on 31 December 2030 to remain valid until they expire, but not beyond twelve months after the new regulation takes effect.

For planning, the conclusion is simple. A Ukrainian manufacturer will be working to MDR-derived national rules at home from 2031, but that alignment gives no standing in the Union today or then. Only a Union conformity route produces the CE marking.

A Ukrainian designated body is not a Union notified body

Technical Regulation 753 speaks of a призначений орган з оцінки відповідності, a conformity assessment body designated under Ukrainian law, and of the Ukrainian mark of conformity with technical regulations, which replaced the earlier term national mark of conformity in 2015. Neither is a Union instrument. A certificate from a Ukrainian designated body permits the Ukrainian mark; it does not permit the CE marking, and it is not listed as a notified body certificate for MDR purposes.

The practical consequence falls on class I devices with special characteristics as much as on higher classes. Under MDR, a sterile, measuring or reusable surgical class I device needs a notified body for those aspects:

"If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." (MDR Article 52(7))

MDR's transitional provisions do not help here either. Article 120 extends certificates issued by Union notified bodies under the Directives, not certificates issued by bodies designated under national law in a third country:

"Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date set out in paragraph 3a of this Article applicable for the relevant risk class of the devices." (MDR Article 120(2))

Ukraine already requires a resident representative from foreign manufacturers

Ukrainian manufacturers know the authorised representative concept from their own law. Point 31 of Technical Regulation 753 requires a non-resident manufacturer placing devices on the Ukrainian market under its own name to appoint one authorised representative responsible for placing them on the market, which must notify Derzhliksluzhba of its location and devices. Annex 1, point 44(1) then requires the representative's name and location on the label, outer packaging or instructions for imported devices.

MDR applies the mirror rule to a Ukrainian manufacturer exporting to the Union:

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))

The Union version carries more weight. The mandate must be accepted in writing and must allow the representative to verify the declaration of conformity and technical documentation, keep them available to competent authorities, and terminate the mandate if the manufacturer acts contrary to MDR. Where the manufacturer has not complied with Article 10, the representative is jointly and severally liable for defective devices (Article 11(5)).

Candidate status changes the timetable, not the rules that apply today

The European Commission records that Ukraine was given a European perspective on 23 June 2022 and that the first intergovernmental conference, formally opening accession negotiations, was held on 25 June 2024. The Association Agreement, including the Deep and Comprehensive Free Trade Area, has been in force since September 2017. None of this changes the status of a Ukrainian manufacturer under MDR. Until accession, Ukraine is a third country, and Article 11 applies in full.

Getting the Union side in place from Kyiv, Lviv or Dnipro

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, the European Commission's March 2022 Notice to Stakeholders states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Medex holds EUDAMED authorised representative SRN TR-AR-000057550. Switzerland and Great Britain require representatives established there (CH-REP and UKRP); Medex does not act in those roles or for the EEA-EFTA states.

The sequence for a Ukrainian manufacturer:

1. Mandate under Article 11(3). A written mandate covering at least all devices of the same generic device group, listing the statutory tasks.

2. Verification. Medex checks that the EU declaration of conformity, the technical documentation and, where applicable, the notified body certificate exist. Medex does not write technical documentation, is not a notified body and does not find distributors.

3. EUDAMED actor registration. The manufacturer registers as an actor and obtains its SRN; the mandate is recorded in EUDAMED against Medex's SRN.

4. Basic UDI-DI and UDI. Basic UDI-DIs per device group and UDI-DIs down to packaging level, with the Annex VI core data, which Medex verifies under Article 11(3)(c).

5. PRRC. Article 15(6) requires the representative to have a person responsible for regulatory compliance "permanently and continuously at their disposal"; Medex's is in-house.

6. Label and IFU. Annex I, Section 23.2(d) requires the representative's name and registered address on the label.

Published annual fees run from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative. See the pricing page for the full table.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Türkiye, Serbia and Israel. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our devices carry the Ukrainian mark of conformity. Does that count in the Union?

No. The Ukrainian mark shows conformity with Ukrainian technical regulations and is issued on Ukrainian conformity assessment. The Union recognises only the CE marking affixed after an MDR conformity assessment. The test reports and validations behind the Ukrainian mark can be reused as evidence.

Once Resolution 759 applies, will our Ukrainian certificate become an MDR certificate?

No. Resolution 759 aligns Ukrainian requirements with MDR, but certificates will still be issued by Ukrainian designated bodies under Ukrainian law. A CE marking requires a notified body designated under MDR, or self-declaration for class I devices without special characteristics.

We are the Ukrainian authorised representative for a foreign brand. Can we also be their EU representative?

Not from Ukraine. An authorised representative under Article 11 must be established in a Member State, or in Türkiye under the Customs Union arrangement. A Ukrainian company cannot hold that mandate until Ukraine accedes.

Our production continues from a relocated site. Does the EUDAMED registration change?

The actor registration follows the legal manufacturer and its registered place of business, not the production site. A move of registered office must be updated in EUDAMED, and the representative's copy of the technical documentation must reflect any change of manufacturing site affecting a notified body certificate.

Sources

Cabinet of Ministers of Ukraine Resolution No. 753 of 2 October 2013, Technical Regulation on medical devices — zakon.rada.gov.ua

Cabinet of Ministers of Ukraine Resolution No. 759 of 10 June 2026, Technical Regulation on medical devices — www.kmu.gov.ua

Technical Regulation on medical devices approved by Resolution No. 759 (full text, PDF) — www.kmu.gov.ua

Derzhliksluzhba, Approval of new Technical Regulations on medical devices (16 June 2026) — www.dls.gov.ua

European Commission, Enlargement and Eastern Neighbourhood: Ukraine — enlargement.ec.europa.eu

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.