Separate representative role
An authorised representative under Ukrainian technical regulations is not automatically the EC REP required for the European Union market.
Sell medical devices in the EU from Ukraine · MDR / IVDR Article 11 
EU Authorized Representative for Ukrainian manufacturers.
Our name goes on the label only after your file stands up to review.
Ukraine has its own medical-device technical regulations and authorised-representative framework. For the European Union market, a Ukrainian manufacturer still needs the separate MDR or IVDR route and an EC REP established in the Union.
For Ukrainian medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or organising EUDAMED responsibilities.
Established in the European UnionWarsaw, Poland · EC REP under MDR and IVDR Article 11
Online intake Secure connection MEDDEV brand serving medical-device companies since 2012 MDR 2017/745 & IVDR 2017/746 Mandate accepted only after review
Manufacturers who have worked with MEDDEV
Ukraine → European Union
Regulatory alignment helps. It does not merge the two legal routes.
Ukraine is bringing its medical-device framework closer to EU rules, but the Ukrainian and Union-market roles remain legally separate. MEDDEV maps the available evidence against the actual EU obligations before accepting representation.
Evidence mapping, not blind duplication
Existing technical, clinical and quality records are reviewed against MDR or IVDR so the team can see what carries over and what remains open.
Continuity under named ownership
The mandate, EUDAMED tasks, labelling and authority communication are assigned to named owners and recorded in writing.
Related briefing: Ukraine is rebuilding its rules on the MDR. What Resolutions 759 and 758 of 10 June 2026 change, and why recognition runs one way.
Official basis: Ministry of Health of Ukraine: technical-regulation guidance, European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.
Local review focus
What usually needs attention for Ukraine manufacturers.
For Ukrainian manufacturers, continuity of records, authorised signatory powers and reliable access to vigilance information are central to the first review. Existing Ukrainian evidence can support the assessment, but the EU mandate must identify the legal manufacturer and the people able to respond during an authority request.
Need the wider comparison? Compare home-market evidence with the EU MDR/IVDR route →
Qualification file
What to prepare for the first EU review.
The initial website form contains no document upload. After the parties and scope are confirmed, MEDDEV provides a controlled transfer route for the records below.
- 01
Ukrainian legal-manufacturer extract, current ownership information and the authorised signatory for the EU mandate.
- 02
Applicable Ukrainian conformity records together with the proposed MDR or IVDR classification and EU conformity route.
- 03
Technical-documentation index, ISO 13485 evidence, certificates where required and product-liability insurance.
- 04
A device list identifying manufacturing sites, critical suppliers, intended EU importers and planned launch countries.
Typical transition gaps
Issues to resolve before the mandate starts.
Legal-entity verification
The contracting manufacturer, owners, signatory authority and payment route need to be documented before liability review.
Continuity of controlled records
Backups, document access, complaint handling and vigilance contacts must remain available if staff or infrastructure changes.
Local-to-EU evidence mapping
Ukrainian conformity records may support the review, but MDR or IVDR declarations, labels and EUDAMED data remain separate outputs.
EUDAMED is no longer a future obligation
Four modules — actor registration, UDI/Devices, notified bodies and certificates, and market surveillance — have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860. For devices placed on the market earlier and still being placed on the market, Regulation (EU) 2024/1860 allows no later than twelve months from publication of the Commission notice, which was published on 27 November 2025. Registration data therefore belongs in the market-entry plan, not after it.
Financial coverage: what the law says, and what we ask for
MDR Article 10(16) — mirrored for in vitro diagnostics by IVDR Article 10(15) — requires manufacturers to have measures in place providing sufficient financial coverage for potential liability under Directive 85/374/EEC, in a manner proportionate to the risk class, type of device and size of the enterprise. It does not prescribe a particular insurance policy. MEDDEV asks to see those measures because Article 11(5) makes the authorised representative legally liable for defective devices on the same basis as, and jointly and severally with, a manufacturer that has not met its Article 10 obligations. Reviewing the arrangement is our acceptance condition, and that provision is why.
Country-specific route
01 02 03
Check this portfolio →
From home-market records to EU representation.
Verify the manufacturer
Confirm the legal entity, ownership, authorised signatory, sites and proposed EU supply chain.
Secure the regulatory file
Establish controlled access to current technical, quality and post-market records and record EU-specific gaps.
Accept the mandate conditionally
Complete insurance and sanctions screening, close acceptance items, then coordinate labelling and EUDAMED work.
Questions from Ukraine
What manufacturers ask before appointment.
Does regulatory alignment with the EU remove the need for an EC REP?
No. A Ukrainian-established manufacturer remains outside the Union and needs the separate Article 11 arrangement for EU market access.
Which entity signs the mandate?
The legal manufacturer named in the technical documentation and product labelling must be verified together with its authorised signatory.
Why do you review ownership and continuity arrangements?
The EC REP carries defined legal duties and may need reliable access to documents and decision-makers during an authority or vigilance case.
Can documents be sent through the initial website form?
No. The form is for qualification only. MEDDEV provides a controlled transfer route after the scope and parties are confirmed.
Acceptance is earned, not purchased
Not every mandate is accepted.
MEDDEV accepts only defined device scopes supported by evidence, working safety controls and a manufacturer we can rely on. A commercial enquiry never guarantees appointment. Our name appears on the label only after the acceptance review is complete.
MEDDEV mandate reviewAcceptance gate
Manufacturer, device and intended purposeAcceptance criterion
Conformity route and regulatory evidenceAcceptance criterion
Safety, post-market and vigilance controlsAcceptance criterion
Communication, response and liability arrangementsAcceptance criterion
Outcome: mandate accepted, conditions issued or mandate declined.
A status worth displaying
Turn regulatory acceptance into a visible trust signal.
Accepted manufacturers may use the mark where professional buyers assess regulatory readiness. Each use must remain connected to the active MEDDEV mandate and its defined device scope.
- Manufacturer websiteAlongside EU market-access information and the represented device portfolio.
- Product catalogueOn pages covering devices included in the accepted mandate.
- Distributor dossierAs a verifiable representation status during onboarding and due diligence.
- Sales presentationFor procurement, partner meetings and trade-fair communication.
Use boundary: the mark must not appear as a CE mark, product certificate or safety approval. It should not be added to the regulated device label, instructions for use or sterile-packaging information panel.
Before you enquire
Know what shapes the review and the fee.
We do not publish a one-size-fits-all price because the mandate depends on the device, portfolio and level of responsibility. The initial review identifies the scope before a fee is proposed.
Device and portfolio
Classification, IVD or medical device route, number of families, intended purpose and higher-risk features.
Evidence readiness
Technical documentation, clinical or performance evidence, quality-system records, certificates and labelling.
Ongoing responsibility
EUDAMED coordination, vigilance, authority response, importer interface, PRRC support and required review depth.
Fee principle: after the qualification review, we provide a defined scope and a proposal matched to the accepted mandate. No document upload is required in the first contact form.
01
Legal manufacturer
Confirm the entity, country of establishment, device family and intended EU market.
02
Core evidence
Have the classification rationale, technical-file index, conformity route and quality evidence available.
03
Post-market readiness
Identify complaint, vigilance, field-safety and authority-response owners before the mandate begins.
Typical review scenarios 01 02 03
The questions we resolve before a mandate starts.
These anonymised composite scenarios reflect recurring qualification patterns. They are not attributed client case studies or performance claims; the exact scope and outcome depend on the manufacturer and device file.
New EU launch
Problem: home-market approval is mistaken for EU access. Work: map MDR/IVDR, labelling, EUDAMED and importer responsibilities. Typical result: a defined launch route and a documented list of open evidence.
Change of EC REP
Problem: the outgoing representative controls records and dates are unclear. Work: plan custody, vigilance ownership and handover steps. Typical result: a controlled transition with responsibilities recorded before the new mandate starts.
Higher-risk review
Problem: a Class IIb, Class III or complex IVD portfolio has unresolved evidence or liability gaps. Work: enhanced file and response-readiness review. Typical result: accept, request defined evidence, or decline before exposure is created.
Regulatory briefings
EUDAMED · Article 123(3)
Cyber Resilience Act
Article 10a MDR
Manufacturers outside the EU
The obligations manufacturers outside the Union ask about most.
Each briefing states the provision it relies on and links to the official text. They are written for companies deciding whether, and in what order, to enter the European market.
Device data falls due on 27 November 2026.
Four modules became mandatory on 28 May 2026. The twelve-month obligation does not cover every device, and the wording decides which.
Read the EUDAMED briefing →Reporting duties start on 11 September 2026.
Products covered by the MDR are excluded. Companion software without a medical purpose, portals and service tools are not.
Read the cybersecurity briefing →Withdrawing a device now takes six months of notice.
The notice goes to the authority of the Member State where the manufacturer or its authorised representative is established.
Read the supply briefing →Not every part of a domestic file has to be rebuilt.
What transfers into a European file, what has no equivalent at home, and where a representative is required by law.
Open the compliance hub → Published acceptance criteria
Six tests every device scope must pass.
Priority goes to complete, traceable applications with a named regulatory owner. Meeting the entry criteria qualifies a scope for a decision; it does not guarantee acceptance.
- 01
Verified legal manufacturer and scope
The legal entity, authorised signatory, manufacturing sites, device families, models and intended purposes are consistent and traceable.
- 02
Defensible EU regulatory route
The qualification, classification and conformity-assessment route are documented, with valid notified-body involvement where required.
- 03
Controlled regulatory evidence
The EU declaration, agreed technical-documentation index, certificates, labelling and registration data describe the same device scope.
- 04
Working safety and post-market controls
Risk management, surveillance, complaints, vigilance, recalls and corrective actions have current records, owners and escalation routes.
- 05
Responsive manufacturer relationship
Named decision-makers can provide records, samples and technical answers and can act within agreed authority-response times.
- 06
Liability and continuity secured
Insurance, contractual responsibility, document access, sanctions screening, change notification and mandate continuity are acceptable.
What the status means: “MEDDEV Mandate Accepted” confirms MEDDEV’s written acceptance of an EC REP mandate for the defined device scope. It is a trust signal about regulatory readiness and the manufacturer relationship. It is not a CE certificate, product approval, independent safety claim or substitute for the applicable conformity assessment.
Meet MEDDEV in your own time zone. Live reference times for manufacturer markets. MEDDEV’s registered office is in Warsaw.
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The people behind your mandate
Director-level governance. Named specialists for regulatory execution.
Mikołaj Junosza-Szaniawski leads mandate governance, risk oversight and international delivery. Marta Junosza-Szaniawska and Barbara Jęcka-Izdebska remain the named specialists for conformity assessment, registration and ongoing regulatory coordination.
MEDDEV Compliance sp. z o.o. · Warsaw, European Union ul. Mydlarska 47, 04-690 Warszawa, Poland biuro@meddev.pl
Check my eligibility → 
Mikołaj Junosza-Szaniawski
Managing Director · EC REP Operations & GovernanceMikołaj brings more than 25 years of experience at KPMG, including as a Director in Audit Assurance, where he oversaw major sustainability-reporting assurance projects. He combines international project governance with a product-life-cycle perspective encompassing LCA, reuse, recyclability and environmental performance. At MEDDEV, he oversees mandate governance, risk escalation, specialist assignment and continuity of manufacturer communication.
25+ years at KPMG Director, Audit Assurance MBA · Carlson School of Management Specialist LCA training · MIT ESG lecturer · Kozminski University Programme manager · EPD Polska
One accountable contact, specialist depth when the device requires it.
The manufacturer does not need to coordinate a loose group of advisers. The named coordinators define the review scope, assign the relevant specialists and remain accountable for communication and the agreed regulatory work.
Regulatory affairsQuality systemsClinical evaluationPhysiciansBiomedical engineeringSoftware and cybersecurityAesthetic devicesPost-market surveillance
Marta Junosza-Szaniawska
Conformity assessment & EC REP mandate reviewMarta coordinates the initial regulatory assessment, defines the file-review scope and confirms whether MEDDEV can accept the representative mandate.
marta.szaniawska@meddev.pl +48 791 480 270
Barbara Jęcka-Izdebska
Registration, notifications & ongoing coordinationBarbara coordinates registration and notification work and remains a named contact for the practical steps that follow appointment.
barbara.jecka@meddev.pl +48 730 354 190