Sell medical devices in the EU from South Korea · MDR / IVDR Article 11

EU Authorized Representative for South Korean manufacturers.

Our name goes on the label only after your file stands up to review.

A manufacturer established in South Korea is outside the European Union for MDR and IVDR purposes. MEDDEV reviews the available home-market evidence, defines the EU file and accepts the Article 11 mandate only when the documentation and liability criteria are met.

For South Korean medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or coordinating EUDAMED responsibilities.

Established in the European UnionWarsaw, Poland · EC REP under MDR and IVDR Article 11

Online intake Secure connection

Apply for MEDDEV mandate review

A short, three-step intake. We confirm eligibility, define the review scope and decide whether to proceed.

Step 1 of 3 · Manufacturer

Full name *

Work email *

Company (manufacturer) *

Regulatory route *

Country *

Device class *

No document upload at this stage · reply usually the same working day · in English

Confidential files are handled separately through one-time access, private EU storage and automatic deletion after expiry. Review our security and data handling controls.

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

South Korea → European Union

The route that made approval easy in Korea is the one that stalls in Europe.

MFDS describes notification for Class I, certification for Class II devices found substantially equivalent to a device already approved, certified or notified, and approval for Class III and Class IV as well as for new Class II devices. Where substantial equivalence is established, MFDS states that clinical trial reports are not required — that is a rule for substantially equivalent devices, not a general exemption for Class II. The European Union also permits a clinical evaluation based on data from an equivalent device, but on its own conditions. Those conditions, not the Korean decision, determine what the EU file needs.

Equivalence exists in both systems, on different terms

Annex XIV of the MDR allows a clinical evaluation to be based on clinical data relating to a device for which equivalence can be demonstrated, taking technical, biological and clinical characteristics into account together. The differences must not have a clinically significant effect on safety or clinical performance, and the justification has to be scientific and supported by sufficient access to data. It is an argument to be built, not a shortcut.

The contract condition is the hard part

Article 61(5) of the MDR is explicit: where the equivalent device was not manufactured by you, two further conditions apply. The two manufacturers must have a contract in place that explicitly allows the second manufacturer full access to the technical documentation on an ongoing basis, and the original clinical evaluation must have been performed in compliance with the Regulation, with clear evidence of that provided to the notified body. For in vitro diagnostics the corresponding provisions sit in the IVDR and its Annex XIII, not here.

So the question becomes: whose data is it

Where a Korean certification relied on equivalence to another company’s device, the EU position has to be established separately: which clinical or performance evidence the manufacturer holds in its own right, and whether an equivalence argument is available at all. Post-market clinical follow-up updates a clinical evaluation; it does not substitute for evidence that has to be in place before conformity assessment and CE marking.

Official basis: MFDS: medical-device approval and review, MDR Article 61 and Annex XIV: clinical evaluation and equivalence, European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.

Local review focus

What usually needs attention for South Korea manufacturers.

South Korean manufacturers can use MFDS and KGMP evidence as part of the EU file, but the Union route still requires its own classification, conformity assessment and post-market responsibilities. A controlled evidence map prevents local approvals from being mistaken for EU authorisation.

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
Per device family: the Korean route actually used — notification, certification on the basis of equivalence, or approval — and, where equivalence was used, which device it was claimed against and who manufactures it.
02
Any contract or data-access arrangement with the manufacturer of the equivalent device, if one exists.
03
Clinical or performance evidence the manufacturer owns outright, separated from data relied on through equivalence.
04
Intended purpose as it will be worded for the EU market, the MDR or IVDR classification rationale, quality-system evidence and the technical-documentation index.

Typical transition gaps

Issues to resolve before the mandate starts.

Equivalence assumed to travel

A Korean certification granted on the basis of substantial equivalence does not carry into the EU by itself. Where the equivalent device belongs to another manufacturer, MDR Article 61(5) requires a contract for ongoing full access to its technical documentation and evidence that its clinical evaluation met the Regulation. Without both, that particular argument is not available, and the IVDR sets out its own performance-evaluation rules for in vitro diagnostics.

Class mapped across, not re-derived

Korea and the EU both use four classes, but the rules differ and Korean IVD classification is not the same scale. Classification has to be argued from the MDR or IVDR rules and from the intended purpose as it will be worded for the Union market.

Quality-system evidence overstated

Korean quality-system conformity assessment is useful context and may reduce duplicated work. There is no formal recognition route into the EU system, and it does not by itself satisfy the quality-management requirements assessed under MDR or IVDR.

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

From home-market records to EU representation.

Trace each approval to its basis

Establish, per device family, whether the Korean decision rested on equivalence and, if so, against whose device. This single question determines the shape of the EU project.

Separate owned data from borrowed data

Identify the clinical and performance evidence the manufacturer holds in its own right, then assess honestly whether an MDR equivalence argument is available or whether evidence has to be generated.

Build the EU file on what survives

Set the classification and conformity route from the Union rules, agree the evidence plan, then coordinate the mandate, labelling and EUDAMED work.

Check this portfolio →

Questions from South Korea

What manufacturers ask before appointment.

Our Class II certification was granted on equivalence. Can we reuse it in the EU?

The certification itself does not transfer, and the equivalence argument may not either. MDR Annex XIV permits a clinical evaluation based on an equivalent device, and Article 61(5) adds two conditions where that device is not yours: a contract giving you full, ongoing access to its technical documentation, and evidence that its clinical evaluation complied with the Regulation. For in vitro diagnostics the equivalent provisions are in the IVDR and its Annex XIII. If you do not have that contract, the honest answer is that the EU evidence base has to be rebuilt — and we would rather tell you that at the start.

Does MFDS approval shorten the EU process at all?

Yes, in substance if not in status. The decision does not carry over, but bench testing, biocompatibility, validation and post-market data generated for Korea can often be reused where they meet MDR or IVDR requirements. What cannot be reused is a conclusion that depended on somebody else’s clinical data.

Is a Korean certification equivalent to a notified body assessment?

No, and the roles are worth separating. Within the Korean system NIDS handles notifications and Class II certification, NIFDS carries out scientific review, and MFDS issues the approval. A notified body is something else entirely: designated under the MDR or IVDR by an EU Member State, and only its assessment supports CE marking where one is required.

Does every manufacturer from this country need an EC REP?

Article 11(1) of the MDR and IVDR states that 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. MDCG 2022-16 explains what “sole” means in practice: across a portfolio a manufacturer can have more than one authorised representative where the devices fall under different generic device groups, but for any one generic device group only one. It is a condition of placing the device on the market, not a formality afterwards.

What is reviewed before the mandate?

MEDDEV reviews the legal manufacturer, device identity, classification, conformity route, technical-documentation index, insurance, vigilance arrangements and sanctions screening.

Can documents be sent through the first contact form?

No. The form is for qualification only. A controlled document-transfer route is provided after scope and parties are confirmed.

Post-project client survey

Post-project ratings from real regulatory work.

56published post-project ratings

97%marked MEDDEV “recommended”

5/5 across five criteria WDI Wise Device Europe Readiness audit · 2015

5/5 across five criteria SensiMed Medical device notification · 2015

5/5 across five criteria Piórex S.A. Medical device registration · 2015

Historical MEDDEV post-project survey across regulatory services. Clients rated knowledge transfer, consultant engagement, subject-matter preparation, problem solving and overall service. The individual ratings shown here are from 2015; the summary figures cover the published set from that survey programme. Comments were optional, so most ratings carry none — and no quotation has been reconstructed or written on a client’s behalf.

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.

Example on a manufacturer website. The issued mark should link to the active MEDDEV mandate and its defined device scope.

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.

Legal manufacturer

Confirm the entity, country of establishment, device family and intended EU market.

Core evidence

Have the classification rationale, technical-file index, conformity route and quality evidence available.

Post-market readiness

Identify complaint, vigilance, field-safety and authority-response owners before the mandate begins.

Check your EC REP readiness →

Typical review scenarios

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

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.

EUDAMED · Article 123(3)

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 →

Cyber Resilience Act

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 →

Article 10a MDR

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 →

Manufacturers outside the EU

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.

Present my device scope →

Meet MEDDEV in your own time zone. Live reference times for manufacturer markets. MEDDEV’s registered office is in Warsaw.

Request a 30-minute online meeting

Vancouver–:–

New York / Toronto–:–

Warsaw–:–

Dubai–:–

Tokyo / Seoul–:–

Sydney–:–

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 & Governance

Mikołaj 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 review

Marta 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 coordination

Barbara 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